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

NCT04955808 | Suspended

• 2 other identifiers: NCI-2017-01572DCP-002
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colon Carcinoma; Kidney Carcinoma; Liver Carcinoma; Malignant Solid Neoplasm; Multiple Myeloma; Prostate Carcinoma; Invasive Carcinoma; Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Acquisition of tissue, blood, and other biospecimens for research purposes

  Will be performed.

  Up to 3 years

Study Arms (1)

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.

Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of tissue and blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Ancillary-correlative (biospecimen collection)

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-correlative (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery to remove tumor tissue

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute Division of Cancer Prevention

Rockville, Maryland, 20850, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Carcinoma, Renal Cell; Carcinoma, Hepatocellular; Multiple Myeloma; Prostatic Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Liver Neoplasms; Liver Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Michelle Bennett

  National Cancer Institute Division of Cancer Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 9, 2021
• Study Start: February 7, 2017
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-02

Locations

US (1)