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Collecting and storing tissue and blood samples from cancer patients

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

Observational National Cancer Institute (NCI) · NCT02474160

This study is collecting and storing blood and tissue samples from cancer patients to help researchers create better models for understanding cancer and testing new treatments.

Quick facts

Study typeObservational
Enrollment5000 (estimated)
Ages2 Months and up
SexAll
SponsorNational Cancer Institute (NCI) NIH
Locations140 sites (Birmingham, Alabama and 139 other locations)
Trial IDNCT02474160 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect and store tissue and blood samples from patients diagnosed with various types of cancer. The samples will be procured during necessary clinical procedures and will be used to create preclinical models for cancer research. By analyzing these samples, scientists hope to develop better models for understanding cancer and testing new cancer therapies. The study focuses on patients with confirmed cancer diagnoses as well as those with indications of cancer pending confirmation.

Who should consider this trial

Good fit: Ideal candidates include patients older than 2 months with a confirmed diagnosis of cancer or those with significant clinical indicators suggesting cancer.

Not a fit: Patients without any clinical suspicion of cancer or those not undergoing evaluation or treatment for cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cancer research models and more effective cancer treatments.

How similar studies have performed: Other studies involving the collection of biological samples for cancer research have shown success in advancing understanding and treatment options, making this approach well-established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Birmingham, Alabama and 139 other locations

+90 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hematopoietic and Lymphatic System NeoplasmMalignant Solid NeoplasmMetastatic Malignant Solid NeoplasmRecurrent Malignant Solid Neoplasm
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.