Study Estimating Association Between Germline Mutations and PD-L1 Expression in Breast Cancer

NCT03495544 | Unknown

• 1 other identifier: ESR-17-12934
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the association between the presence of germline DNA-repair genes mutations and PD-L1 expression level in tumour and immune cells in breast cancer. No additional procedures besides those already used in the routine clinical practice will be applied to the patients.

Conditions

Hereditary Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of PD-L1 expression in breast cancer

  Number of samples of PD-L1 high expression in tumor and immune cells in FFPE breast tumor tissue and number of samples of PD-L1 low expression in tumor and immune cells in FFPE breast tumor tissue . The report will be represented as "PD-L1 high" or "PD-L1 low".

  January 2018-January 2019

Secondary Outcomes (2)

• Diagnostic performance of inherited gene mutations in breast cancer

  January 2018-January 2019

• Association between germline DNA-repair genes mutations and PD-L1 expression level in in breast cancer

  January 2018-January 2019

Study Arms (2)

Hereditary BC

Pathogenic germline mutations in DNA-repair genes (TP53 MLH1 MSH2 MSH6 PMS2 EPCAM APC MUTYH CDKN2A CDK4 ATM KIT PDGFRA CDH1 CTNNA1 PRSS1 SPINK1 BRCA1 BRCA2 FANCI FANCL PALB2 RAD51B RAD51C RAD54L RAD51D CHEK1 CHEK2 CDK12 BRIP1 PPP2R2A BARD1 PARP1 STK11 XRCC3)

Diagnostic Test: PD-L1 expression

Sporadic BC

Without germline mutations in DNA-repair genes (TP53 MLH1 MSH2 MSH6 PMS2 EPCAM APC MUTYH CDKN2A CDK4 ATM KIT PDGFRA CDH1 CTNNA1 PRSS1 SPINK1 BRCA1 BRCA2 FANCI FANCL PALB2 RAD51B RAD51C RAD54L RAD51D CHEK1 CHEK2 CDK12 BRIP1 PPP2R2A BARD1 PARP1 STK11 XRCC3)

Diagnostic Test: PD-L1 expression

Interventions

PD-L1 expression DIAGNOSTIC_TEST

IHC testing of PD-L1 expression level in tumor tissue samples

Hereditary BC; Sporadic BC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients, female aged between 18-80yrs with breast cancer

You may qualify if:

• \. The voluntary obtained informed consent signed by both the subject and the investigator.
• \. Females 18 years age or more. 3. Histologically confirmed BC with known hormone receptors and HER2neu receptors status, Grade of tumor, diagnosed before enrolment into the study.
• \. Availability of FFPE tissue samples received prior to any type of antitumor treatment start. Tumour tissue samples must be satisfied IHC requirements for PD-L1 testing.
• \. Ability of blood samples receiving for NGS germline mutations testing. 6. Completed medical records (stage, receptors status, demographic data)

You may not qualify if:

• Any evidence of uncontrolled system pathology, active infections, active bleeding diathesis, renal graft, including virus hepatitis B, C or HIV.

Sponsors & Collaborators

• Tatarstan Cancer Center: lead

Study Sites (1)

Tatarstan Cancer Cente

Kazan', Tatarstan Republic, 420029, Russia

RECRUITING

MeSH Terms

Conditions

Breast Cancer, Familial

Central Study Contacts

Marat Gordiev

CONTACT

+79172399490; marat7925@gmail.com

Rafail Enikeev

CONTACT

+79274027390; alba352007@yandex.ru

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 12, 2018
• Study Start: January 1, 2018
• Primary Completion: March 17, 2019
• Study Completion: July 1, 2019
• Last Updated: April 12, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

RU (1)