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.
Brief Title
Biospecimen Collection in Identifying Genetic Changes in Patients With Breast, Prostate, Colorectal, Liver, or Kidney Cancer or Multiple Myeloma Undergoing Surgery
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Breast Carcinoma
Colon Carcinoma
Invasive Carcinoma
Kidney Carcinoma
Liver Carcinoma
Malignant Solid Neoplasm
Multiple Myeloma
Prostate Carcinoma
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
* 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
Inclusion 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).
* 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).
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04955808
Org Class
Nih
Org Full Name
National Cancer Institute (NCI)
Org Study Id
NCI-2017-01572
Overall Status
Suspended
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Early Onset Malignancies Initiative (EOMI): Molecular Profiling of Breast, Colon, Kidney, Liver, Multiple Myeloma, and Prostate Among Racially and Ethnically Diverse Populations
Primary Outcomes
Outcome Description
Will be performed.
Outcome Measure
Acquisition of tissue, blood, and other biospecimens for research purposes
Outcome Time Frame
Up to 3 years
Secondary Ids
Secondary Id
NCI-2017-01572
Secondary Id
DCP-002
Secondary Id
DCP-002
Secondary Id
DCP-002
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients undergoing surgery to remove tumor tissue
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org
Investigator Phone