Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry (PROGECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02302742
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Priyanka Sharma, University of Kansas

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).

Condition or disease
Breast Cancer Hereditary Breast and Ovarian Cancer

Detailed Description:
This study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. This information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations
Study Start Date : March 2011
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Triple Negative Breast Cancer patients
No intervention
Germline HBOC Mutation Carriers
No intervention


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC [ Time Frame: 5 years ]
  2. . Predictors of response to neo/adjuvant chemotherapy in patients with TNBC [ Time Frame: 5 years ]
  3. Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
A baseline blood draw is collected as a part of this registry. If a study participant has a personal history of cancer and a tumor sample is available, the participant may give consent for the tissue to be used as a part of the study. Additional optional specimen collection sub-studies may also be offered to participants.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Academic Center & Community Clinics
Criteria

Inclusion criteria include:

Triple Negative Breast Cancer

  • ER/PR <10% and HER negative per current ASCO/CAP guidelines
  • Stages I-IV
  • Any age at diagnosis
  • Patient must be within 5 years of diagnosis
  • Eligible regardless of genetic testing status
  • Genetic testing recommended for patients meeting NCCN and Medicare guidelines

AND/OR

Germline mutation Carriers

  • Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type/site of cancer
  • Healthy patients harboring mutations also eligible
  • There is no time limit from the time of diagnosis of cancer and enrollment.
  • Eligible regardless of personal history of cancer

Exclusion Criteria include:

Triple Negative Breast Cancer -Patient is not within five years of diagnosis

Germline mutation Carriers:

-Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302742


Contacts
Layout table for location contacts
Contact: Kelsey Schwensen (913) 588-6079 kschwensen@kumc.edu

Locations
Layout table for location information
United States, Kansas
Hays Medical Center Dreiling-Schmidt Cancer Institute Recruiting
Hays, Kansas, United States, 67601
Contact: Josette Klaus    785-623-5761      
KCCC West Recruiting
Kansas City, Kansas, United States, 66112
Contact: Kristina Sharpe-Pringle    913-328-3206      
Menorah Medical Center Recruiting
Overland Park, Kansas, United States, 66209
Contact: Amy Nelson    913-498-7892      
KCCC Overland Park Recruiting
Overland Park, Kansas, United States, 66210
Contact: Christy Kuechler    913-234-0459      
Overland Park Regional Medical Center Recruiting
Overland Park, Kansas, United States, 66215
Contact: Amy Nelson    913-498-7892      
Salina Regional Health Center - Tammy Walker Cancer Center Recruiting
Salina, Kansas, United States, 67401
Contact: Melanie Leepers, RN, MBA    785-452-7038      
The University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Joshua M Staley    913-588-8548    jstaley2@kumc.edu   
United States, Missouri
Centerpoint Regional Medical Center Recruiting
Independence, Missouri, United States, 64057
Contact: Amy Nelson    816-698-8249      
Truman Medical Center Recruiting
Kansas City, Missouri, United States, 64108
Contact: Nikki Malomo    816-404-4093      
KCCC South Recruiting
Kansas City, Missouri, United States, 64131
Contact: Adrienne Harris-Connell    816-823-6640      
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Jennifer Feeback    816-276-4000      
KCCC - North Recruiting
Kansas City, Missouri, United States, 64154
Contact: Nicole Jenci    816-584-4879      
KCCC Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64064
Contact: Jan Ward    816-350-5825      
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Priyanka Sharma, MD The University of Kansas Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Layout table for additonal information
Responsible Party: Priyanka Sharma, Professor of Medicine, University of Kansas
ClinicalTrials.gov Identifier: NCT02302742    
Other Study ID Numbers: KUMC 12614
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Keywords provided by Priyanka Sharma, University of Kansas:
Triple Negative Breast Cancer
TNBC
Hereditary Breast and Ovarian Cancer
HBOC
Prospective Registry
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Triple Negative Breast Neoplasms
Hereditary Breast and Ovarian Cancer Syndrome
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn