Biospecimen Collection in Identifying Genetic Changes in Patients With Breast, Prostate, Colorectal, Liver, or Kidney Cancer or Multiple Myeloma Undergoing Surgery

February 23, 2024 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. 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 Type

Observational

Enrollment (Estimated)

2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20850
        • National Cancer Institute Division of Cancer Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgery to remove tumor tissue

Description

Inclusion Criteria:

  • 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
    • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Biospecimen Collection
Undergo collection of tissue and blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acquisition of tissue, blood, and other biospecimens for research purposes
Time Frame: Up to 3 years
Will be performed.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Michelle Bennett, National Cancer Institute Division of Cancer Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2017

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2017-01572 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • DCP-002 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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