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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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INCLUSION CRITERIA:
- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05600933
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Institute (NCI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Steven A Rosenberg, M.D.
Principal Investigator Affiliation	National Cancer Institute (NCI)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Solid Tumors, Hematologic Malignancy, Gastrointestinal Cancer, Liver Cancer, Pancreatic Cancer, Melanoma, Pre-Malignancy, Lung Cancer
Study Website:	View Trial Website

Additional Details

Background:

- Recent advances and insights into the molecular pathogenesis of cancer have led to the development of novel molecular and biologic targeted therapies for the treatment of advanced cancer participants.

A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies.

- The development of immuno-oncology therapeutics across a wide spectrum of malignancies has emphasized a need to understand the intratumoral immunologic landscape of metastatic cancer.

The techniques of cultivating and examining tumor infiltrating lymphocytes developed in the Surgery Branch can be expanded and refined by the exploration of solid tumors.

- The Surgery Branch, NCI has an interest in identifying novel molecular and biologic targets to facilitate the development of future cancer therapies for solid and hematologic malignancies.

Through close collaborations with the Surgical Oncology Program and Thoracic Surgery Branch, our internal staff surgeons, and our medical oncology staff clinicians, we are uniquely positioned to acquire and perform important studies on solid tumor tissue and bone marrow to help identify therapeutic targets that may have significant clinical ramifications. Objective: 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. Eligibility: Participants >=18 years of age with suspected or confirmed malignancies planning diagnostic or therapeutic intervention from which biologic samples may be obtained. Design:

- A tissue acquisition trial in which tissues will be obtained at the time of intervention.

- Tissue and blood will be processed at the time of collection, stored and then transferred to the Surgery Branch Cell Production Facility for further processing.

- No investigational therapy will be given.

- It is anticipated that 1200 participants will be enrolled.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

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Bethesda 4348599, Maryland 4361885

Status

Address

National Institutes of Health Clinical Center

Bethesda 4348599, Maryland 4361885, 20892

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