RecruitingNot Applicable

Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer

United States1,800 participantsStarted 2013-07-21

Plain-language summary

Background: \- Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC). Objectives: \- To collect tissue samples for use in studying new ways to treat tumors. Eligibility: * Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC. * Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care. Design: * Before their procedure, participants will have a small blood sample taken. * Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours. * For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis. * Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * Participants must be 2 years of age or older. Note: Participants greater than or equal to 2 and \< 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the biospecimen sampling (e.g., blood, urine, ascites, bile, or \[clinically indicated\] resected tumor tissue) does not add risk to the clinically indicated procedures. * Participants who have premalignant, primary, or metastatic solid tumors based upon either radiographic or clinical suspicion, biochemical testing, a genetic predisposition, or histological/cytological analysis that requires surgery or biopsy as part of the diagnosis, prevention, treatment, and/or follow-up. * Participants without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated. * Participants should have laboratory and physical examination parameters within acceptable limits prior to biopsy or surgery. * Participants must be planning to undergo surgery or biopsy as part of their normal treatment plan. * Ability of participant, parent/guardian or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: None.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is focused on collecting tumor tissue samples rather than testing a new drug or treatment, does participating change anything about my actual cancer care or the biopsy and surgery I'm already scheduled to have?
2The trial lists several GI cancers — colorectal, gastric, bile duct, cholangiocarcinoma, and pancreatic — so can you tell me specifically how my type and stage of cancer fits with what they're looking to study, and whether my tissue would actually be useful to them?
3Because the goal is to find new molecular targets for future therapies rather than to benefit me directly right now, is there any realistic chance I could personally benefit from what researchers learn from my sample, or is this purely a contribution to future patients?
4Are there any risks beyond what I'd face from my standard biopsy or surgery that I should know about before agreeing to donate tissue for this study?
5If my tissue reveals something notable about my tumor's biology during their research, would I or my care team ever be informed of those findings, and could that information influence my treatment plan?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Collection of biologic samples from participants undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets

Timeframe: 2 month

Trial details

NCT IDNCT01915225

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2035-06-30

Contact for this trial

Cathleen E Hannah, C.R.N.P.

(240) 858-7006 foregut@mail.nih.gov

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