Omics of Cancer: OncoGenomics

Cancer Clinical Trial

Official title:

Omics of Cancer: OncoGenomics

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05431439
• Other study ID #: 10000046
• Secondary ID: 000046-C
• Status: Withdrawn
• 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
• 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Weeks and older

Eligibility

• INCLUSION CRITERIA:

• Age >= 4 weeks

• Participants must have:

• 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., 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

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	examine tumor samples	oncogenic drivers using next-generation whole genome (WGS), exome (WES), and/or RNA sequencing	Ongoing throughout study
Secondary	analyze germline samples	known or novel cancer predisposition genes using WGS, WES, and/or RNA sequencing	Ongoing throughout study

External Links

•   NIH Clinical Center Detailed Web Page