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| ID | Type | Description | Link |
|---|---|---|---|
| 000046-C |
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No participants enrolled
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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....
Background
Objective
-To establish a registry in which clinical data of participants with cancer or cancer predisposition is linked to the genomic database of analyzed samples
Eligibility
Design
Participants will be enrolled at NIH
Collected samples will be studied to:
Expected accrual 50-500 participants per year. Total protocol accrual goal 5,000 participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with cancer or cancer predisposition |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| determine the feasibility of longitudinal collection and analyses of liquid biopsies alongside the analysis of matched tumor samples | to characterize heterogeneity and to identify therapeutically resistant clones | Ongoing throughout study |
| examine tumor samples |
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INCLUSION CRITERIA:
Age >= 4 weeks
Participants must have:
OR
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
OR
--be scheduled to undergo surgery or biopsy for routine patient care on another research or standard of care protocol
OR
--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.
EXCLUSION CRITERIA:
None
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Javed Khan, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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.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.
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.
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.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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oncogenic drivers using next-generation whole genome (WGS), exome (WES), and/or RNA sequencing |
| Ongoing throughout study |
| analyze germline samples | known or novel cancer predisposition genes using WGS, WES, and/or RNA sequencing | Ongoing throughout study |