Breast CarcinomaNCT04955808
Biospecimen Collection in Identifying Genetic Changes in Patients With Breast, Prostate, Colorectal, Liver, or Kidney Cancer or Multiple Myeloma Undergoing Surgery
An observational study of Breast Carcinoma and Colon Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This research trial studies how well biospecimen collection works in identifying genetic changes in patients with breast, prostate, colorectal, liver, or kidney cancer or multiple myeloma undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Colon Carcinoma, Invasive Carcinoma
- What is being tested?
- Biospecimen Collection and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- How many people
- 2,400 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2017to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery to remove tumor tissue
Who may be able to join
- Patients with either:
- Histologically confirmed invasive carcinoma or multiple myeloma OR
- Clinical diagnosis of carcinoma or multiple myeloma OR
- Suspected clinical diagnosis of multiple myeloma
- Patients with one of following tumor types and age ranges:
- Breast cancer diagnosis at ages 18-45
Show all 22Show fewer
- Colon cancer diagnosis at ages 18-55
- Kidney cancer at diagnosis at ages 18-50 (American Indian or Alaska Native [AIAN] and non-Hispanic Whites [NHW] only)
- Liver cancer diagnosis at ages 18-55
- Prostate cancer diagnosis at ages 18-55
- Multiple myeloma diagnosis at ages 18-50
- Patients whose tumor specimen was collected or will be collected during one of the following routine procedures:
- Surgery to remove cancer OR
- Routine biopsy procedures performed to confirm a histologic diagnosis OR
- Routine biopsy procedure performed to obtain additional tumor material for routine prognostic or predictive biomarkers OR
- Routine procedure to place a vascular access device prior for systemic therapy
- Patients who have received no therapy for their cancer other than surgery, irrespective of stage
- Collection of specimens from living patients:
- Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol
- Collection of specimens from deceased patients:
- Banked tissue samples and/or banked biologic fluid specimens of deceased patients may be used as long as all samples or specimens are properly de- identified prior to submission
- Sites must use the Central Institutional Review Board for the National Cancer Institute (NCI CIRB).
Who cannot join
- Patients who do not meet criteria for an early onset malignancy
- Prior systemic therapy or radiation therapy for their malignancy
- Tumor does not meet quality metrics
- Patient refused consent for use of tissue for research activities included in the Early Onset Malignancies Initiative
- A diagnosis of a synchronous invasive malignancy
- Patients with a history of invasive cancer or hematologic malignancy in preceding 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute Division of Cancer Prevention
Rockville, Maryland, 20850
About this study
Official title: Early Onset Malignancies Initiative (EOMI): Molecular Profiling of Breast, Colon, Kidney, Liver, Multiple Myeloma, and Prostate Among Racially and Ethnically Diverse Populations
This research trial studies how well biospecimen collection works in identifying genetic changes in patients with breast, prostate, colorectal, liver, or kidney cancer or multiple myeloma undergoing surgery. Studying samples collected during surgery may add to the understanding of cancer by looking for the genetic changes that cause early cancer onset in people of certain racial and ethnic groups.
Read the detailed description
PRIMARY OBJECTIVE:
- To acquire tissue and blood, and other biospecimens for research purposes during procedures for clinical care to accelerate our understanding of the molecular basis of early onset cancers occurring in racial and/or ethnic minority populations through the application of genome analysis technologies, including large- scale genome sequencing and clinical data analysis.
OUTLINE:
Patients undergo collection of tumor tissue during surgery. Patients also undergo blood samples. Samples collected may undergo genetic analysis including whole exome sequencing.
After completion of study, patients are followed for up at 6 and 12 months.
- Conditions
- Breast Carcinoma, Colon Carcinoma, Invasive Carcinoma, Kidney Carcinoma, Liver Carcinoma, Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Carcinoma, Renal Cell, Carcinoma, Hepatocellular, Multiple Myeloma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of tissue and blood samples
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-correlative (biospecimen collection) | Patients undergo collection of tumor tissue during surgery. Patients also undergo blood samples. Samples collected may undergo genetic analysis including whole exome sequencing. Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of tissue, blood, and other biospecimens for research purposes
Will be performed.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start7 Feb 2017
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Due to slow accrual on this trial, we will allow sites time to work on close-out procedures and filling out necessary paperwork before taking the steps to forma
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michelle Bennett, Principal investigator, National Cancer Institute Division of Cancer Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955808
- Sponsor's protocol ID
- NCI-2017-01572
- Other IDs
- NCI-2017-01572, DCP-002, DCP-002, DCP-002
- Status last verified
- Feb 2026
- First submitted
- 8 Jul 2021
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Onset Malignancies Initiative (EOMI): Molecular Profiling of Breast, Colon, Kidney, Liver, Multiple Myeloma, and Prostate Among Racially and Ethnically Diverse Populations
- ClinicalTrials.gov ID
- NCT04955808
- Acronym / sponsor ID
- NCI-2017-01572
- Conditions
- Breast Carcinoma, Colon Carcinoma, Invasive Carcinoma, Kidney Carcinoma, Liver Carcinoma, Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Due to slow accrual on this trial, we will allow sites time to work on close-out procedures and filling out necessary paperwork before taking the steps to forma
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jul 2021 (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.
This research trial studies how well biospecimen collection works in identifying genetic changes in patients with breast, prostate, colorectal, liver, or kidney cancer or multiple myeloma undergoing surgery. Studying samples collected during surgery may add to the understanding of cancer by looking for the genetic changes that cause early cancer onset in people of certain racial and ethnic groups.
Detailed description
PRIMARY OBJECTIVE:
- To acquire tissue and blood, and other biospecimens for research purposes during procedures for clinical care to accelerate our understanding of the molecular basis of early onset cancers occurring in racial and/or ethnic minority populations through the application of genome analysis technologies, including large- scale genome sequencing and clinical data analysis.
OUTLINE:
Patients undergo collection of tumor tissue during surgery. Patients also undergo blood samples. Samples collected may undergo genetic analysis including whole exome sequencing.
After completion of study, patients are followed for up at 6 and 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (biospecimen collection) | – | Procedure: Biospecimen Collection, Other: Laboratory Biomarker AnalysisPatients undergo collection of tumor tissue during surgery. Patients also undergo blood samples. Samples collected may undergo genetic analysis including whole exome sequencing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery to remove tumor tissue
Key inclusion criteria (22 listed)
- Patients with either:
- Patients with one of following tumor types and age ranges:
- Patients whose tumor specimen was collected or will be collected during one of the following routine procedures:
- Patients who have received no therapy for their cancer other than surgery, irrespective of stage
- Collection of specimens from living patients:
Key exclusion criteria (6 listed)
- Patients who do not meet criteria for an early onset malignancy
- Prior systemic therapy or radiation therapy for their malignancy
- Tumor does not meet quality metrics
- Patient refused consent for use of tissue for research activities included in the Early Onset Malignancies Initiative
- A diagnosis of a synchronous invasive malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of tissue and blood samples | Procedure or surgery | Ancillary-correlative (biospecimen collection) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-correlative (biospecimen collection) |
Primary outcome
Acquisition of tissue, blood, and other biospecimens for research purposes
Time frame: Up to 3 years
Will be performed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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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.
Michelle Bennett principal investigator
National Cancer Institute Division of Cancer Prevention
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 Breast Carcinoma and Colon Carcinoma, 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 22 inclusion and 6 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: paused, as of the sponsor's last update on 13 May 2026. 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?
Results are not available in the source record.
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?
Acquisition of tissue, blood, and other biospecimens for research purposes (time frame: Up to 3 years). 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 13 May 2026; AzTrials last refreshed its copy on 4 Nov 2026.