Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05431439 |
| Other study ID # |
10000046 |
| Secondary ID |
000046-C |
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 27, 2023 |
| Est. completion date |
September 27, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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....
Description:
Background
- Cancer is the second leading cause of disease-related mortality in the US and the
primary leading cause of US disease-related mortality in individuals aged 40-79
- One of the missions of the Oncogenomics Section is to identify new targets and develop
new therapeutic strategies for currently incurable malignancies as well as to improve
the quality of life for adults and children with cancer. Overall, approximately
1,918,030 individuals, 983,160 males, and 934,870 females will be diagnosed with cancer
in 2022
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
- Age >= 4 weeks
- Participants must have a diagnosis of any tumor, malignancy, pre-malignant disorder, 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., including 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 or be willing to provide
blood and/or saliva specimens. Note: blood will not be drawn in children < 3 years old
Design
- Participants will be enrolled at NIH
- Collected samples will be studied to:
- Examine tumor samples for oncogenic drivers using next-generation whole genome
sequencing (WGS), whole exome sequencing (WES), panel, or RNA sequencing
- Analyze germline samples for known or novel cancer predisposition genes using WGS,
WES, or panel sequencing
- Determine the feasibility of longitudinal collection and analyses of liquid
biopsies alongside the analysis of matched tumor samples
- Establishment of Epstein-Barr virus (EBV) transformed cell lines from blood and/or
bone marrow for medical research
- New methodologies such as proteomics and metabolomics analysis in the investigation
of cellular, molecular, genetic, and genomic biology, to probe for new therapeutic
targets, and to develop new treatment approaches
- Expected accrual 50-500 participants per year. Total protocol accrual goal 5,000
participants
