Solid TumorsNCT05600933
Prospective Procurement of Tumor Tissue to Identify Novel Therapeutic Targets and Study the Tumor Microenvironment
An observational study of Solid Tumors and Hematologic Malignancy, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Hematologic Malignancy, Gastrointestinal Cancer
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 15 Jun 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Solid Tumors, Hematologic Malignancy, Gastrointestinal Cancer, Liver Cancer, Pancreatic Cancer, Melanoma
- Keywords
- Biologic Samples, Intratumoral Immunologic Landscape, Tumor Infiltrating Lymphocytes, Immuno-Oncology Therapeutics, Natural History
- Medical subject headings
- Hematologic Neoplasms, Gastrointestinal Neoplasms, Liver Neoplasms, Pancreatic Neoplasms, Melanoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of surgery or biopsy
Secondary outcomes (1)
To collect detailed history, demographic, treatment data, and perioperative findings.
To collect detailed history, demographic, treatment data, and perioperative findings in order to categorize specimens.
Measured: At time of consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start15 May 2023
- Primary completion15 Jun 2033 (estimated)
- Study completion15 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven A Rosenberg, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600933
- Sponsor's protocol ID
- 10000958
- Other IDs
- 000958-C
- Status last verified
- 13 Oct 2026
- First submitted
- 25 Oct 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP