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NCT02474160ClinicalTrials.gov

Collection and Storage of Tissue and Blood Samples From Patients With Cancer

Patient-Derived Models Tissue Procurement Protocol for the National Cancer Institute (NCI)

RecruitingTaking participants now, according to the registry record.
Contact this study

In brief

This study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn…

Observational5,000 participants sought140 sites1 country

Categories

Oncology100%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

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.

  • Registered after enrolment began (about 29 days after the recorded start)First posted 2015-06-17; recorded start 2015-05-19
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
  • A comparison group is not stated in the registry recordThe record describes a single study arm
  • Whether the study is blinded is not stated in the registry recordNo masking information is recorded
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • 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.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (National Cancer Institute LAO)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 4 conditions.
  • Lead sponsor type recorded as: not stated in the registry record.

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: 140 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration3/5

    Registered within 30 days of the study start

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 5,000 participants (target), run at 140 sites.

How this score is built
  • Enrolment36/40

    5,000 participants (target)

  • Site count24/25

    140 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 133 months

  • Sponsor scale1/10

    National Cancer Institute LAO has led 2 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

This study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.

PRIMARY OBJECTIVE: I. To procure biologic tissues and materials to generate preclinical models of cancer. OUTLINE: This is an observational study. Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and will be stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.

Conditions

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Malignant Solid Neoplasm

Eligibility

SexAll
Ages2 Months – No maximum
Healthy volunteersNo
Sampling methodNON_PROBABILITY_SAMPLE

Study population

Patients undergoing evaluation and/or treatment for cancer

Eligibility as written in the registry

Inclusion Criteria: * Patients older than 2 months of age who are being evaluated, treated, or enrolled in a clinical trial for cancer at participating sites * Patients with a histologically or cytologically confirmed diagnosis of cancer * Patients without histologically or cytologically confirmed diagnosis of cancer, but for whom approval has been requested and received from the coordinating site study coordinator * Requests for coordinating site approval should only be made if the patient's existing work-up at the time of the request demonstrates a combination of two or more of the following indicating the greater likelihood of a cancerous process in the assessment of the treating physician: * Radiographic imaging (computed tomography \[CT\], magnetic resonance imaging \[MRI\], etc.) * Elevated tumor markers * Clinical symptoms * Documented risk factors, known genetic changes (mutation, deletion, fusion, etc.), and/or known familial cancer history or syndrome * Complete blood count (CBC) w/differential indicative of a probable hematologic malignancy * If the patient will be undergoing surgical resection at a later time and will be accessible to approach for study participation at that time, resected material following cancer diagnosis confirmation is preferred * Important: Additional medical, genetic and/or demographic work-up should not be obtained solely for determination of eligibility for protocol 9846 by these criteria. Once available, final histology must be confirmed to the coordinating site detailing the cancer diagnosis for patients enrolled based on the above criteria * Patients with a newly diagnosed primary and/or metastatic solid tumor or hematologic malignancy for which they have not yet received treatment * Patients with a solid tumor or hematologic malignancy that is recurrent, newly metastasized, or progressing while on treatment indicated by: * Radiographic evidence of tumor growth, re-growth, and/or new metastases, OR * Documentation by the treating physician of clinical disease progression, OR * CBC w/differential and/or flow cytometry for hematologic malignancies * Patients currently undergoing treatment (adjuvant, neoadjuvant, etc.) * Specimen collection should occur as distant in time from the most recent drug administration as possible (e.g., after completion of a treatment cycle and immediately prior to initiation of the next cycle) * Specimens should not be collected from patients between doses within a single treatment cycle * Confirmation of viable residual malignancy and/or \< 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report * Patients with ongoing partial response (PR) or stable disease (SD) are eligible * Confirmation of viable malignancy and/or \< 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the NCI coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report * Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol * For pediatric patients, ability and willingness to assent to participation, using an explanation that is understandable/age appropriate, as well as receiving parental permission. Signature requirements for pediatric patients can be adjusted based on local guidelines Exclusion Criteria: * Patients with cancer-like syndromes and/or blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia/hypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS) * Patients with invasive fungal infections * Patients with active and/or uncontrolled bacterial, fungal, or viral infections or who are still recovering from an infection * Actively febrile patients with uncertain etiology of febrile episode * All antibiotics prescribed for the treatment of a bacterial infection should be completed at least 1 week (7 days) prior to collection * Patients with a hematologic malignancy who are treated with an antibiotic, anti-fungal, and/or anti-viral medication for an active infection who then remain on the treatment for prophylaxis following resolution of the infection as assessed by the treating physician are not excluded * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics * Patients receiving antibiotics, antifungals, and/or antivirals for prophylaxis are permissible * Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible * Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e., quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HCV, HBV, or HIV; testing for HBV, HCV, HIV or other infections for eligibility will be performed only if clinically indicated * Patients with hepatitis A as indicated by anti-hepatitis A virus (HAV) IgM reactivity * Patients that are anti-HAV IgG reactive only are eligible * Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR)

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 typeObservational
PhaseNot stated in the registry record
AllocationNot stated in the registry record
Intervention modelNot stated in the registry record
Primary purposeNot stated in the registry record
MaskingNot stated in the registry record
Enrolment5,000 participants sought

Sponsor and collaborators

  • National Cancer Institute LAO Sponsor
  • National Cancer Institute (NCI) Collaborators

Arms and interventions

  • Observational (tissue and blood procurement)

    Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.

Interventions

  • Other Cytology Specimen Collection Procedure

    Procurement of tissue and blood samples

Outcome measures

  1. Primary outcome

    Procurement of tissue and blood specimens for research purposes

    Tissues and venous blood will be stored, implanted immediately to generate patient-derived xenografts (which require fresh, viable cells), or placed immediately into in vitro cell culture to generate patient-derived cell lines (which require fresh, viable cells).

    Time frame Up to 5 years

Dates

Start dateMay 19, 2015 (actual)
Primary completionMay 4, 2026 (estimated)
CompletionMay 4, 2026 (estimated)
First postedJune 17, 2015 (estimated)
Last updatedMarch 5, 2026
Results postedNot stated in the registry record
Status last verifiedMarch 2026

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

Locations

22 sites are recruiting

United States

FacilityCityState or regionStatus
Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn ArborMichiganActive, not recruiting
PCR OncologyArroyo GrandeCaliforniaActive, not recruiting
MultiCare Auburn Medical CenterAuburnWashingtonActive, not recruiting
Augusta University Medical CenterAugustaGeorgiaRecruiting
UCHealth University of Colorado HospitalAuroraColoradoActive, not recruiting
Virginia Mason Bainbridge Island Medical CenterBainbridge IslandWashingtonActive, not recruiting
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMarylandActive, not recruiting
Bronson Battle CreekBattle CreekMichiganSuspended
University of Alabama at Birmingham Cancer CenterBirminghamAlabamaSuspended
OSF Saint Joseph Medical CenterBloomingtonIllinoisActive, not recruiting
Illinois CancerCare-BloomingtonBloomingtonIllinoisSuspended
Central Care Cancer Center - BolivarBolivarMissouriSuspended
Parkland Health Center-Bonne TerreBonne TerreMissouriSuspended
Dana-Farber Cancer InstituteBostonMassachusettsActive, not recruiting
Cox Cancer Center BransonBransonMissouriSuspended
Illinois CancerCare-CantonCantonIllinoisSuspended
Saint Francis Medical CenterCape GirardeauMissouriSuspended
Southeast Cancer CenterCape GirardeauMissouriSuspended
Memorial Hospital of CarbondaleCarbondaleIllinoisSuspended
Illinois CancerCare-CarthageCarthageIllinoisSuspended
Centralia Oncology ClinicCentraliaIllinoisSuspended
Cancer Center of Kansas - ChanuteChanuteKansasSuspended
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth CarolinaSuspended
John H Stroger Jr Hospital of Cook CountyChicagoIllinoisRecruiting
Marshfield Clinic-Chippewa CenterChippewa FallsWisconsinActive, not recruiting
Decatur Memorial HospitalDecaturIllinoisRecruiting
Cancer Care Specialists of Illinois - DecaturDecaturIllinoisRecruiting
Cancer Center of Kansas - Dodge CityDodge CityKansasSuspended
City of Hope Comprehensive Cancer CenterDuarteCaliforniaActive, not recruiting
Duke University Medical CenterDurhamNorth CarolinaActive, not recruiting
Marshfield Clinic Cancer Center at Sacred HeartEau ClaireWisconsinActive, not recruiting
Crossroads Cancer CenterEffinghamIllinoisSuspended
Cancer Center of Kansas - El DoradoEl DoradoKansasSuspended
Illinois CancerCare-EurekaEurekaIllinoisSuspended
Virginia Mason Federal Way Medical CenterFederal WayWashingtonActive, not recruiting
Cancer Center of Kansas - Fort ScottFort ScottKansasSuspended
Mercy Hospital Fort SmithFort SmithArkansasRecruiting
Western Illinois Cancer Treatment CenterGalesburgIllinoisSuspended
Illinois CancerCare-GalesburgGalesburgIllinoisSuspended
MultiCare Gig Harbor Medical ParkGig HarborWashingtonActive, not recruiting
Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand RapidsMichiganRecruiting
Trinity Health Grand Rapids HospitalGrand RapidsMichiganSuspended
Cancer and Blood Specialists-HendersonHendersonNevadaActive, not recruiting
M D Anderson Cancer CenterHoustonTexasActive, not recruiting
Cancer Center of Kansas-IndependenceIndependenceKansasSuspended
MU Health Care Goldschmidt Cancer CenterJefferson CityMissouriSuspended
Mercy Hospital JoplinJoplinMissouriRecruiting
Freeman Health SystemJoplinMissouriRecruiting
Ascension Borgess HospitalKalamazooMichiganSuspended
West Michigan Cancer CenterKalamazooMichiganSuspended

90 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

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

https://xmedica.io/trials/ctgov/NCT02474160