Collecting tumor tissue samples from patients undergoing surgery or biopsy for cancer
Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors
This study is collecting tissue samples from cancer patients having surgery or biopsies to see if they can find new ways to treat different types of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1800 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01915225 on ClinicalTrials.gov |
What this trial studies
This study aims to collect tissue samples from patients with solid tumors who are scheduled for surgical procedures or biopsies at the National Institutes of Health Clinical Center. The collected samples will be used to identify novel molecular and biologic therapeutic targets that could lead to new cancer treatments. Participants will also have a small blood sample taken, and some may undergo leukapheresis. The study focuses on various types of cancers, including colorectal, gastric, and pancreatic neoplasms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older, as well as children aged 2 and older, who have a solid tumor and are scheduled for a biopsy or surgery.
Not a fit: Patients without solid tumors or those not undergoing a clinically indicated surgical procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of new and more effective treatments for various types of cancer.
How similar studies have performed: Other studies have successfully utilized tissue procurement for cancer research, indicating that this approach is both established and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan M Hernandez, M.D. — National Cancer Institute (NCI)
- Study coordinator: Cathleen E Hannah, C.R.N.P.
- Email: foregut@mail.nih.gov
- Phone: (240) 858-7006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.