NeoplasmsNCT05431439
Omics of Cancer: OncoGenomics
An observational study of Neoplasms and Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 weeks and older
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2023to 27 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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....
Read the detailed 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
- Keywords
- Oncogenomics, Malignancies, Therapeutic Strategies, Human Genome Project, Cancer, Tumor Genome, Natural History
- Medical subject headings
- 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 |
|---|---|---|
| Cohort 1 | Participants with cancer or cancer predisposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 yrs
Secondary outcomes (3)
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
Measured: Ongoing throughout study
examine tumor samples
oncogenic drivers using next-generation whole genome (WGS), exome (WES), and/or RNA sequencing
Measured: Ongoing throughout study
analyze germline samples
known or novel cancer predisposition genes using WGS, WES, and/or RNA sequencing
Measured: Ongoing throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start27 Sep 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Javed Khan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431439
- Sponsor's protocol ID
- 10000046
- Other IDs
- 000046-C
- Status last verified
- Sep 2023
- First submitted
- 17 Jun 2022
- Last updated
- 29 Sep 2023
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omics of Cancer: OncoGenomics
- ClinicalTrials.gov ID
- NCT05431439
- Acronym / sponsor ID
- 10000046
- Keywords
- Oncogenomics, Malignancies, Therapeutic Strategies, Human Genome Project, Cancer, Tumor Genome, Natural History
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with cancer or cancer predisposition |
Who may qualify
- Ages
- 4 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
establish a registry in which clinical data of participants with cancer or cancer predisposition is linked to the genomic database of analyzed samples
Time frame: 20 yrs
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
3 secondary outcomes
determine the feasibility of longitudinal collection and analyses of liquid biopsies alongside the analysis of matched tumor samples
Time frame: Ongoing throughout study
examine tumor samples
Time frame: Ongoing throughout study
analyze germline samples
Time frame: Ongoing throughout study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javed Khan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
establish a registry in which clinical data of participants with cancer or cancer predisposition is linked to the genomic database of analyzed samples (time frame: 20 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.