Breast Cancer Clinical Trial
Biospecimen Collection in Identifying Genetic Changes in Patients With Breast, Prostate, Colorectal, Liver, or Kidney Cancer or Multiple Myeloma Undergoing Surgery
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.
Full 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.
Eligibility Criteria
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
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There is 1 Location for this study
Rockville Maryland, 20850, United States
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