NCT05334069ClinicalTrials.gov

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Blinded Reference Set for Multicancer Early Detection Blood Tests

RecruitingTaking participants now, according to the registry record.

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In brief

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory…

Observational2,000 participants sought745 sites1 country

Registered in 1 registry

ClinicalTrials.govNCT05334069Open this record at ClinicalTrials.govSynced 2 weeks ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2022-04-19; recorded start 2022-08-18
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 95 other studies in this databaseCounted from the lead sponsor named in the record (Alliance for Clinical Trials in Oncology)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 62 conditions.
Lead sponsor type recorded as: other.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 745 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study: 2,000 participants (target), run at 745 sites.

How this score is built

Enrolment33/40
2,000 participants (target)
Site count25/25
745 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 55 months
Sponsor scale7/10
Alliance for Clinical Trials in Oncology has led 96 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

PRIMARY OBJECTIVE: I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection. SECONDARY OBJECTIVES: I. Evaluate test performance at the time of initial cancer diagnosis by tumor type. II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage. OUTLINE: Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration. After completion of study, participants are followed up at 1 year.

Conditions

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Ann Arbor Stage I Lymphoma
Ann Arbor Stage II Lymphoma
Ann Arbor Stage III Lymphoma
Ann Arbor Stage IV Lymphoma
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Gastroesophageal Junction Adenocarcinoma
Head and Neck Carcinoma
Hematopoietic and Lymphoid Cell Neoplasm
Invasive Breast Carcinoma
Kidney Carcinoma
Malignant Hepatobiliary Neoplasm
Malignant Solid Neoplasm
Melanoma
Muscle-Invasive Bladder Carcinoma
RISS Stage I Plasma Cell Myeloma
RISS Stage II Plasma Cell Myeloma
RISS Stage III Plasma Cell Myeloma
Sarcoma
Stage I Bladder Cancer AJCC v6 and v7
Stage I Breast Cancer AJCC v7
Stage I Colorectal Cancer AJCC v6 and v7
Stage I Esophageal Cancer AJCC V7
Stage I Gastric Cancer AJCC V7
Stage I Lung Cancer AJCC v7
Stage I Ovarian Cancer AJCC v6 and v7
Stage I Pancreatic Cancer AJCC v6 and v7
Stage I Prostate Cancer AJCC v7
Stage I Uterine Corpus Cancer AJCC v7
Stage II Bladder Cancer AJCC v6 and v7
Stage II Breast Cancer AJCC v6 and v7
Stage II Colorectal Cancer AJCC v7
Stage II Esophageal Cancer AJCC v7
Stage II Gastric Cancer AJCC v7
Stage II Lung Cancer AJCC v7
Stage II Ovarian Cancer AJCC v6 and v7
Stage II Pancreatic Cancer AJCC v6 and v7
Stage II Prostate Cancer AJCC v7
Stage II Uterine Corpus Cancer AJCC v7
Stage III Bladder Cancer AJCC v6 and v7
Stage III Breast Cancer AJCC v7
Stage III Colorectal Cancer AJCC v7
Stage III Esophageal Cancer AJCC v7
Stage III Gastric Cancer AJCC v7
Stage III Lung Cancer AJCC v7
Stage III Ovarian Cancer AJCC v6 and v7
Stage III Pancreatic Cancer AJCC v6 and v7
Stage III Prostate Cancer AJCC v7
Stage III Uterine Corpus Cancer AJCC v7
Stage IV Bladder Cancer AJCC v7
Stage IV Breast Cancer AJCC v6 and v7
Stage IV Colorectal Cancer AJCC v7
Stage IV Esophageal Cancer AJCC v7
Stage IV Gastric Cancer AJCC v7
Stage IV Lung Cancer AJCC v7
Stage IV Ovarian Cancer AJCC v6 and v7
Stage IV Pancreatic Cancer AJCC v6 and v7
Stage IV Prostate Cancer AJCC v7
Stage IV Uterine Corpus Cancer AJCC v7
Thyroid Gland Carcinoma

Eligibility

Eligibility
Sex	All
Ages	40 Years – 75 Years
Healthy volunteers	Yes
Sampling method	NON_PROBABILITY_SAMPLE

Study population

Patients with a cancer diagnosis and participants without cancer and without suspicion of cancer and with a high suspicion of cancer

Eligibility as written in the registry

Inclusion Criteria: * Participants with a cancer diagnosis: Documentation of disease: * Histologic documentation: Histologically confirmed diagnosis of invasive cancer * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma * For leukemia: Type (chronic lymphocytic leukemia \[CLL\], chronic myeloid leukemia \[CML\], acute lymphoblastic lymphoma \[ALL\], acute myeloid leukemia \[AML\]) * For lymphoma: Stage I-IV based on Ann Arbor staging * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS) * One of the following tumor types: * Colorectal * Bladder * Head and neck * Hepatobiliary * Lung * Lymphoma * Leukemia * Ovary \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Pancreas \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Multiple myeloma * Gastric, esophageal or gastroesophageal * Breast * Thyroid * Kidney * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Endometrium * Prostate * Melanoma \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Sarcoma * Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention * Participants with a cancer diagnosis: Age \>= 40 and =\< 75 * Participants with a cancer diagnosis: No known current pregnancy by self-report * Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis * Participants with a cancer diagnosis: Willingness to provide blood samples for research use * Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL * Participants with a cancer diagnosis: No history of organ transplantation * Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish \* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages * Participants without a cancer diagnosis and without suspicion of cancer: Age \>= 40 and =\< 75 * Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report * Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) * Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use * Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL * Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation * Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish \* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages * Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw \* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma * Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs * Participants with a high suspicion of cancer: Age \>= 40 and =\< 75 * Participants with a high suspicion of cancer: No known current pregnancy by self-report * Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis * Participants with a high suspicion of cancer: Willingness to provide blood samples for research use * Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL * Participants with a high suspicion of cancer: No history or organ transplantation * Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Observational
Phase	Not stated in the registry record
Allocation	Not stated in the registry record
Intervention model	Not stated in the registry record
Primary purpose	Not stated in the registry record
Masking	Not stated in the registry record
Enrolment	2,000 participants sought

Sponsor and collaborators

Alliance for Clinical Trials in Oncology Sponsor
National Cancer Institute (NCI) Collaborators

Arms and interventions

Screening (questionnaire, biospecimen collection)
Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration.

Interventions

Procedure Biospecimen Collection
Undergo collection of tissue and blood samples
Other Questionnaire Administration
Complete questionnaire

Outcome measures

Primary outcome
Provision of blinded reference set of cancer versus non-cancer blood samples
Diagnostic ability will be assessed across the entire cohort of 2000 subjects by estimating the sensitivity and specificity with 95% confidence intervals.
Time frame Up to 1 year
Secondary outcome
Test performance at the time of initial cancer diagnosis by tumor type
Diagnostic ability is assessed within each cancer type and within each cancer type and stage combination by estimating the sensitivity and specificity with 95% confidence intervals. The width of these confidence intervals will vary by sample size and the sensitivity and specificity rates.
Time frame Up to 1 year
Secondary outcome
Test performance at the time of initial cancer diagnosis by clinical stage
Diagnostic ability is assessed within each cancer stage and within each cancer type and stage combination by estimating the sensitivity and specificity with 95% confidence intervals. The width of these confidence intervals will vary by sample size and the sensitivity and specificity rates.
Time frame Up to 1 year

Dates

Dates
Start date	August 18, 2022 (actual)
Primary completion	January 31, 2027 (estimated)
Completion	February 28, 2027 (estimated)
First posted	April 19, 2022 (actual)
Last updated	September 2, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

614 sites are recruiting

United States

United States
Facility	City	State or region	Status
Providence Regional Cancer System-Aberdeen	Aberdeen	Washington	Recruiting
Riverwood Healthcare Center	Aitkin	Minnesota	Recruiting
Cleveland Clinic Akron General	Akron	Ohio	Recruiting
Summa Health System - Akron Campus	Akron	Ohio	Recruiting
Mayo Clinic Health System in Albert Lea	Albert Lea	Minnesota	Recruiting
University of New Mexico Cancer Center	Albuquerque	New Mexico	Recruiting
Presbyterian Kaseman Hospital	Albuquerque	New Mexico	Recruiting
Lovelace Medical Center-Saint Joseph Square	Albuquerque	New Mexico	Recruiting
Lovelace Women's Hospital	Albuquerque	New Mexico	Recruiting
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	Recruiting
MyMichigan Medical Center Gratiot	Alma	Michigan	Recruiting
MyMichigan Medical Center Alpena	Alpena	Michigan	Recruiting
OSF Saint Anthony's Health Center	Alton	Illinois	Recruiting
The Don and Sybil Harrington Cancer Center	Amarillo	Texas	Recruiting
Mary Greeley Medical Center	Ames	Iowa	Recruiting
McFarland Clinic - Ames	Ames	Iowa	Recruiting
Community Hospital of Anaconda	Anaconda	Montana	Recruiting
Alaska Women's Cancer Care	Anchorage	Alaska	Recruiting
Providence Alaska Medical Center	Anchorage	Alaska	Recruiting
Katmai Oncology Group	Anchorage	Alaska	Recruiting
Anchorage Radiation Therapy Center	Anchorage	Alaska	Suspended
Alaska Breast Care and Surgery LLC	Anchorage	Alaska	Recruiting
Alaska Oncology and Hematology LLC	Anchorage	Alaska	Recruiting
Anchorage Associates in Radiation Medicine	Anchorage	Alaska	Recruiting
Anchorage Oncology Centre	Anchorage	Alaska	Suspended
AnMed Health Cancer Center	Anderson	South Carolina	Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic	Ankeny	Iowa	Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan	Recruiting
Aspirus Cancer Care-Antigo-Volm Cancer Center	Antigo	Wisconsin	Recruiting
ThedaCare Regional Cancer Center	Appleton	Wisconsin	Recruiting
ThedaCare Regional Medical Center - Appleton	Appleton	Wisconsin	Recruiting
PCR Oncology	Arroyo Grande	California	Recruiting
Mission Hope Medical Oncology - Arroyo Grande	Arroyo Grande	California	Recruiting
AdventHealth Infusion Center Asheville	Asheville	North Carolina	Recruiting
Duluth Clinic Ashland	Ashland	Wisconsin	Recruiting
Northwest Wisconsin Cancer Center	Ashland	Wisconsin	Recruiting
Harold Alfond Center for Cancer Care	Augusta	Maine	Recruiting
UCHealth University of Colorado Hospital	Aurora	Colorado	Recruiting
Advocate Outpatient Center - Aurora	Aurora	Illinois	Recruiting
Rush-Copley Medical Center	Aurora	Illinois	Recruiting
Rocky Mountain Cancer Centers-Aurora	Aurora	Colorado	Active, not recruiting
The Medical Center of Aurora	Aurora	Colorado	Suspended
Rocky Mountain Regional VA Medical Center	Aurora	Colorado	Recruiting
Mount Sinai Comprehensive Cancer Center at Aventura	Aventura	Florida	Recruiting
Saint Alphonsus Cancer Care Center-Baker City	Baker City	Oregon	Recruiting
AIS Cancer Center at San Joaquin Community Hospital	Bakersfield	California	Recruiting
Mercy Oncology and Hematology - Clayton-Clarkson	Ballwin	Missouri	Recruiting
MedStar Franklin Square Medical Center/Weinberg Cancer Institute	Baltimore	Maryland	Recruiting
Mercy Medical Center	Baltimore	Maryland	Recruiting
Sinai Hospital of Baltimore	Baltimore	Maryland	Recruiting

695 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 2, 2026
Site added
1 site added (745 total)
744745
August 5, 2026
Site removed
1 site removed (744 total)
745744

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05334069

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Study population

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

United States

Study documents

Changes over time