Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT01915225

Conditions

Colorectal Neoplasms

Gastric Neoplasms

Cholangiocarcinoma

Bile Duct Cancer

Pancreas Cancer

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Colorectal Neoplasms

Gastric Neoplasms

Cholangiocarcinoma

Bile Duct Cancer

Pancreas Cancer

Study ID

NCT01915225

Start date

Jul 21, 2013

Status verified date

Jun 15, 2026

Primary completion date

Jun 30, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

1800 participants

Anticipated

Interventions and Outcome Measures

Arms

1/ Cohort 1

Participants with or without solid tumors in whom diagnostic, preventative, or therapeutic intervention is being performed

Primary outcome measure

  • 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 [ Time Frame: 2 month ]

Central Contacts and Locations

Central contacts

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

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

Jonathan M Hernandez, M.D.

(240) 760-6072jonathan.hernandez@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 8, 2026

Last verified

Jun 15, 2026

Keywords

  • Tissue Procurement
  • Surgery
  • Metastasectomy
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-08.