Health Condition 1: D05- Carcinoma in situ of breast Health Condition 2: C50- Malignant neoplasm of breast
Conditions
Interventions
None listed
Sponsors
Pfizer
Eligibility
Inclusion criteria
Inclusion criteria: The patients with suspected familial/hereditary breast cancers will be offered genetic counselling. Pre-test counseling will involve acquiring detailed family history and offer genetic testing based on criteria suggested by NCCN guidelines for Breast and Ovarian Cancer. We expect to recruit up to 100 patients with the following criteria in 2 years based on our current estimates of patient enrollment. Following is the criteria for our target audience relevant to patients regularly treated at our hospital. According to NCCN guidelines, a patient with breast cancer with at least one of the following: i. Diagnosed at age =50 y with unknown or limited family history; or a second breast cancer diagnosed at any age; ii. =1 close blood relatives with breast, ovarian, pancreatic, or high-grade (Gleason score =7) or intraductal prostate cancer at any age iii. Diagnosed at age =60 y with triple-negative breast cancer iv. Diagnosed at any age with male breast cancer v. =1 close relatives with breast cancer at age =50 y or ovarian, pancreatic, or metastatic or intraductal prostate cancer at any age; or vi. =2 close relatives with breast or prostate cancer (any grade) at any age. vii. Patients with Triple Negative Breast Cancer
Exclusion criteria
Exclusion criteria: Patients under 20 years old and patients or their families unable to decide for oneself will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Genetic counselling for familial and hereditary breast cancers. b. Genetic testing for breast cancer patients. c. Standard operating procedures for genetic counseling and multidisciplinary treatment management plan backed by genetics for breast cancer patients. d. In-house design and validation of a cost-efficient multi gene panel for breast cancer. e. Develop necessary biobanking and clinical trials capability of our hospital and research center. Timepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Expanded breast cancer sequencing panel for genetic testingTimepoint: Baseline | — |
Countries
India
Contacts
Public ContactRama Rao Damerla
Manipal Academy of Higher Education
Outcome results
None listed