Prospective Procurement of Tumor Tissue to Identify Novel Therapeutic Targets and Study the Tumor Microenvironment

NCT05600933 | Enrolling By Invitation

• 2 other identifiers: 10000958000958-C
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Many advances have been made in cancer treatments, but more research is needed. Comparing samples of cancerous tissue to samples of normal, noncancerous tissues may help find differences between them. These differences may help researchers find new ways to treat cancer. Objective: To collect tissues and blood samples from people with known or suspected cancer. The samples will be used to help identify new targets for cancer treatments. Eligibility: People aged 18 years and older with a known or suspected cancer that requires surgery or biopsy. Design: Participants will be screened. They will answer questions about their health. They can do this on the phone or in person. Researchers will collect information from participants medical records. Data may include information about any prior or current cancers. Data about other medical conditions may also be collected. Participants will have blood drawn. Some of the blood will be tested for HIV and hepatitis B and C. Some of the blood will be used for genetic research. Participants will have tissue samples collected during surgeries or biopsies. These are procedures the participants would have had as part of their standard care. No new procedures will be done just for this study. Researchers may also seek out samples from prior procedures the participant had done. Participants will remain in the study for 6 months. They may have blood drawn again. Researchers may also collect tissue samples from any procedures performed during that time.

Conditions

Solid Tumors; Hematologic Malignancy; Gastrointestinal Cancer; Liver Cancer; Pancreatic Cancer; Melanoma; Pre-Malignancy; Lung Cancer

Keywords

Biologic Samples; Intratumoral Immunologic Landscape; Tumor Infiltrating Lymphocytes; Immuno-Oncology Therapeutics; Natural History

Outcome Measures

Primary Outcomes (1)

• To collect biologic samples from participants undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors and hematologic malignancies

  To collect biologic samples from participants undergoing diagnostic or therapeutic interventions for known or suspected cancer for the purpose of identifying novel molecular and biologic therapeutic targets and studying the intratumoral immune landscape.

  At time of surgery or biopsy

Secondary Outcomes (1)

• To collect detailed history, demographic, treatment data, and perioperative findings.

  At time of consent

Study Arms (2)

1 - premalignant, primary or metastatic solid tumor

Participants \>= 18 with a suspected or confirmed solid tumor malignancy that requires surgery or biopsy.

2 - known or suspected hematologic malignancy

Participants \>= 18 who have a known or suspected hematologic malignancy that requires surgery or biopsy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects from both sexes and all racial/ethnic groups who are undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors or hematologic malignancies

You may qualify if:

• Age \>= 18 years
• Willing to undergo serologic testing for HIV, hepatitis B and C
• Participants who have a known or suspected cancer that requires surgery or biopsy as a part of the standard of care diagnosis, treatment and/or follow up.
• Note: Participants will not be enrolled exclusively for the procurement of tissue samples.
• Able and willing to sign an informed consent document.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hematologic Neoplasms; Gastrointestinal Neoplasms; Liver Neoplasms; Pancreatic Neoplasms; Melanoma; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steven A Rosenberg, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 1, 2022
• Study Start: May 15, 2023
• Primary Completion (Estimated): June 15, 2033
• Study Completion (Estimated): June 15, 2033
• Last Updated: May 12, 2026

Record last verified: 2026-05-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data will be available during the study and indefinitely.@@@@@@Genomic data will be available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data will be made available via dbGaP through requests to the data custodians.

Locations

US (1)