Omics of Cancer: OncoGenomics

NCT05431439 | Withdrawn

• 2 other identifiers: 10000046000046-C
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Cancer is a leading cause of death in the United States. Researchers want to know more about how cancer develops and grows. They want to understand more about cancers that run in families. This information will help them find better ways to diagnose and treat cancer. Researchers need to collect data from many people who either have cancer or who may get cancer. Objective: To establish a registry of data about people with cancer. The natural history registry will be linked to a database with information about their genetics. Eligibility: People aged 4 weeks and older with a diagnosis of any cancer. People with precancerous conditions or with a family history of an inherited cancer are also needed. Design: Participants will answer questions about their medical history. This visit can be in-person or by phone. Participants will provide blood and saliva samples. Researchers will also collect any samples the participants may already have given in the past. These may include tumor biopsies or samples of bone marrow or other body fluids. No blood will be collected from children younger than 3 years. No new surgeries or biopsies will be done for this study. The samples will be used for genetic research. Researchers will follow up with participants once a year. They will get an updated medical history. They will ask for any new biopsies or other tissue samples. They may collect new saliva and blood samples. Participants may continue in the study for the rest of their lives....

Conditions

Neoplasms; Cancer

Keywords

Oncogenomics; Malignancies; Therapeutic Strategies; Human Genome Project; Cancer; Tumor Genome; Natural History

Outcome Measures

Primary Outcomes (1)

• establish a registry in which clinical data of participants with cancer or cancer predisposition is linked to the genomic database of analyzed samples

  perform systematic genetic and genomic analysis to enrolled participants treated at the Center for Cancer Research (CCR, NCI) and all Divisions of NCI for the identification of biomarkers and targets of potential therapeutic actionability

  20 yrs

Secondary Outcomes (3)

• determine the feasibility of longitudinal collection and analyses of liquid biopsies alongside the analysis of matched tumor samples

  Ongoing throughout study

• examine tumor samples

  Ongoing throughout study

• analyze germline samples

  Ongoing throughout study

Study Arms (1)

Cohort 1

Participants with cancer or cancer predisposition

Eligibility Criteria

• Age: 4 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a trial to establish a registry in which clinical data of participants with cancer or cancer predisposition is linked to a database of analyzed samples. Participants will be enrolled in the protocol at the NIH Clinical Center from the NIH CC patient population or or from referrals from an extramural facility or treating physicians.

You may qualify if:

• Age \>= 4 weeks
• Participants must have:
• diagnosis of any tumor, malignancy, pre-malignant disorder
• evidence of an inherited cancer syndrome based on family history and/or other manifestations of the syndrome (i.e., polyposis, plexiform neurofibromas, myelodysplastic syndrome)
• Participants must
• have biospecimen (e.g., tumor, normal, blood, bone marrow, serum, plasma, or any other specimen) that has been previously collected and is available for research analysis
• be scheduled to undergo surgery or biopsy for routine patient care on another research or standard of care protocol
• be willing to provide blood and/or saliva specimens. Note: does not apply to children \< 3 years old
• The ability of participant or parent/guardian to understand and the willingness to sign a written consent document.

You may not qualify if:

• None

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

Neoplasms

Study Officials

• Javed Khan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: September 27, 2023
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are 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 are made available via dbGaP through requests to the data custodians.

Locations

US (1)