Clinical trials: Germline Mutation Abnormality
Adnexal Mass, Germline BRCA1 Gene Mutation
Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
The objective of this project is to validate a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early…
- Conditions
- Adnexal Mass, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Hereditary Breast and Ovarian Cancer
- Trial name
- OVA360 (NCT04668521)
- Testing
- OVA360
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- Aspira Women's Health
Pancreatic Cancer
Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial
The goal of this clinical research study is to learn if Niraparib can help to control metastatic pancreatic cancer. The safety of this drug will also be studied.
- Trial name
- NIRA-PANC (NCT03553004)
- Testing
- Niraparib Treatment
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- University of Kansas Medical Center
Breast Cancer Metastatic
Cohort Study of Patients With HER2-negative MBC and BRCA 1/2 Pathogenic Mutation
The purpose of this study is to investigate the prevalence germline pathogenic BRCA1/2 mutation in a large group of potential candidate of PARP inhibitors, among the unselected patients with HER2-negative unresectable locally…
- Trial name
- BRCAm (NCT04368442)
- Where
- South Korea
- Volunteers
- 583 people
- Sponsor
- Samsung Medical Center
Tubo-ovarian Carcinoma, High-grade Serous Carcinoma
Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer
FIMBRIMENOP-2402 study aims to evaluate the long-term management of cancer risks in premenopausal women who have a genetic predisposition to tubo-ovarian or primary peritoneal carcinoma, such as mutations in BRCA1, BRCA2, RAD51C…
- Conditions
- Tubo-ovarian Carcinoma, High-grade Serous Carcinoma, Primary Peritoneal Carcinoma Stage III, Primary Peritoneal Carcinoma Stage IV
- Trial name
- FIMBRIMENOP (NCT06726330)
- Testing
- Fimbriectomy Followed by Delayed Oophorectomy (F-DO), Bilateral Salpingo-Oophorectomy
- Where
- 23 sites in France
- Volunteers
- 1,100 people
- Sponsor
- Centre Oscar Lambret
Genetic Predisposition to Disease, Breast Cancer Female
Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition
The goal of this sequential study design is to increase genetic testing in those meeting national clinical guidelines. The main question it aims to answer is: which intervention is most effective in uptake of genetic testing for…
- Conditions
- Genetic Predisposition to Disease, Breast Cancer Female, Ovarian Cancer, Hereditary Breast and Ovarian Cancer
- Trial name
- NCT05721326
- Testing
- Sequential EHR Communications
- Where
- United States
- Volunteers
- 1,283 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Cancer
Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer.
- Trial name
- NCT01670500
- Testing
- Cisplatin, Cyclophosphamide, Doxorubicin
- Where
- 15 sites in United States
- Volunteers
- 118 people
- Sponsor
- Beth Israel Deaconess Medical Center
Solid Tumor, Solid Tumor, Adult
UCSF Biobank for Hereditary Cancers and Tumor-Associated Mutations
This is a non-therapeutic clinical research biorepository protocol designed to obtain, store, and clinically annotate biospecimens from participants with hereditary cancers.
- Conditions
- Solid Tumor, Solid Tumor, Adult, Somatic Mutation, Solid Tumor, Unspecified, Adult
- Trial name
- NCT06895681
- Testing
- Blood Sample, Tissue Sample, Excess fluid Sample
- Sponsor
- University of California, San Francisco
Germline Mutation, Myelodysplastic Syndromes
Study of Individuals and Families With Aberrations in DDX41 or Similar Cancer Predisposition Variants
Background: Hereditary hematopoietic malignancy (HHM) syndromes are a group of inherited disorders that raises the risk of blood cancers.
- Conditions
- Germline Mutation, Myelodysplastic Syndromes, Acute Myeloid Leukemia
- Trial name
- NCT07019155
- Where
- United States
- Volunteers
- 510 people
- Sponsor
- National Cancer Institute (NCI)
Stomach Neoplasms, Stomach Cancer
Hereditary Gastric Cancer Syndromes: An Integrated Genomic and Clinicopathologic Study of the Predisposition to Gastric Cancer
Background: Gastric cancers are cancers of the stomach. Hereditary ones are passed from parent to child. Researchers want to gather data about hereditary gastric cancers.
- Conditions
- Stomach Neoplasms, Stomach Cancer, Gastric Adenocarcinoma and Proximal Polyposis of the Stomach (GAPPS), Hereditary Diffuse Gastric Cancer (HDGC)
- Trial name
- NCT03030404
- Where
- United States
- Volunteers
- 733 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Advanced Solid Tumor
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated…
- Trial name
- NCT04890613
- Testing
- CX-5461
- Where
- 8 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- Senhwa Biosciences, Inc.
Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Advanced or Metastatic Solid Tumors With Germline PTEN Inactivating Mutations
TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of TAS-117 in patients with advanced or metastatic solid tumors (excluding primary brain tumors)…
- Trial name
- NCT04770246
- Testing
- TAS-117
- Where
- 8 sites in United States, Austria and 2 more
- Volunteers
- 17 people
- Sponsor
- Taiho Oncology, Inc.
Germline Mutation Abnormality, Pancreatic Cancer
Germline Mutations in Pancreatic Adenocarcinoma
This study will assess the hereditary component of pancreatic cancer in the largest series of patients up to date through the parallel analysis of 62 cancer-associated genes.
- Conditions
- Germline Mutation Abnormality, Pancreatic Cancer, Predisposition, Genetic, Hereditary Cancer
- Trial name
- PaMPA (NCT03982446)
- Testing
- Mutations
- Where
- Greece
- Volunteers
- 549 people
- Sponsor
- Hellenic Cooperative Oncology Group
Breast Cancer, BRCA 1 Gene Mutation
A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
This study aims to learn whether a handheld robotic device, called the HandX, can help surgeons safely perform a minimally invasive nipple-sparing mastectomy.
- Conditions
- Breast Cancer, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Hereditary Breast Carcinoma
- Trial name
- ATHENA I (NCT07292246)
- Testing
- Endoscopic nipple sparing mastectomy, HandX endoscopic instrument
- Where
- Greece
- Volunteers
- 15 people
- Sponsor
- Vasileios Kalles
Cowden's Disease, Cowden's Syndrome
Double-Blind Trial of Everolimus for Improving Social Abilities in PTEN Germline Mutations
The goal of this study is to examine the safety and treatment effects of everolimus in adults and children with PTEN Hamartoma Tumor Syndrome (PHTS) who experience social difficulties.
- Conditions
- Cowden's Disease, Cowden's Syndrome, Lhermitte-Duclos Disease, Cerebellum Dysplastic Gangliocytoma
- Trial name
- NCT07218575
- Testing
- Everolimus blinded oral capsules
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Boston Children's Hospital
Advanced Malignant Neoplasm, ATM Gene Mutation
Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes
This phase II trial studies how well talazoparib works in treating patients with cancers that have returned after a period of improvement, do not respond to treatment, or have spread to other parts of the body, and have…
- Conditions
- Advanced Malignant Neoplasm, ATM Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Trial name
- NCT02286687
- Testing
- Laboratory Biomarker Analysis, Pharmacological Study, Talazoparib
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Neoplasms, Germline BRCA1 Gene Mutation
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and…
- Conditions
- Breast Neoplasms, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Benign Breast Disease
- Trial name
- MARRES (NCT04585074)
- Testing
- Robotic or endoscopic nipple sparing mastectomy, Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)
- Where
- 18 sites in South Korea
- Volunteers
- 2,000 people
- Sponsor
- Severance Hospital
Breast Cancer, Pancreas Cancer
Impact of Consumption of Ultra-processed Foods in Individuals at High Risk of Cancer
The U-TRANS study was initiated by Gustave Roussy, which is its sponsor*. It is part of the Interception Program and aims to reduce the consumption of ultra-processed foods in order to improve the overall quality of the diet…
- Conditions
- Breast Cancer, Pancreas Cancer, Colon Cancer, Lynch Syndrome
- Trial name
- U-TRANS (NCT07436312)
- Testing
- educational workshop on nutrition + additional intervention on UPF tool and how to use it
- Where
- 3 sites in France
- Volunteers
- 170 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8
Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer
This phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic).
- Conditions
- Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT04090567
- Testing
- Cediranib, Ceralasertib, Olaparib
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Neoplasms, Breast, Carcinoma of Breast
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
- Conditions
- Neoplasms, Breast, Carcinoma of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation
- Trial name
- BRAVO (NCT01905592)
- Testing
- niraparib, Physician's choice
- Where
- 104 sites in United States, Belgium and 12 more
- Volunteers
- 216 people
- Sponsor
- Tesaro, Inc.
BRCA1 Mutation Carrier, BRCA2 Mutation Carrier
Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This phase II trial studies how well veliparib works in treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond to treatment.
- Conditions
- BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Ovarian Epithelial Tumor, Recurrent Fallopian Tube Carcinoma
- Trial name
- NCT01540565
- Testing
- Laboratory Biomarker Analysis, Veliparib
- Where
- 153 sites in United States
- Volunteers
- 52 people
- Sponsor
- National Cancer Institute (NCI)