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

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ClinicalTrials.gov Identifier: NCT02302742
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Priyanka Sharma, University of Kansas

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 750 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 2021
Estimated Study Completion Date : March 2022


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



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.


Information from the National Library of Medicine

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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"


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
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Contact: Carolyn Lehn (913) 588-6079 clehn@kumc.edu

Locations
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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: Alice Wang    913-588-6079    ywang9@kumc.edu   
Contact: Karissa Finke    (913) 588- 6079    kfinke@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
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Principal Investigator: Priyanka Sharma, MD The University of Kansas Medical Center

Additional Information:

Publications of Results:
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Responsible Party: Priyanka Sharma, Associate Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT02302742     History of Changes
Other Study ID Numbers: KUMC 12614
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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:
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Breast Neoplasms
Ovarian Neoplasms
Triple Negative Breast Neoplasms
Hereditary Breast and Ovarian Cancer Syndrome
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Carcinoma, Ovarian Epithelial
Breast Diseases
Skin Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Genetic Diseases, Inborn