Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genetic Predisposition to Disease

Disease Susceptibility

Breast Diseases

Skin Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Herbal and Botanical

All Drugs and Chemicals

Cola

Comparison to psychological, medical and emotional Influencing communication and achievement factors to Oncogenetics tests

Behaviour

The purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

The risk associated with a genetic predisposition is among the various forms of risk, the strongest identifiable risk . It enables to offer people at risk an appropriate medical care (screening, prevention ) the clinical benefit is validated today. The person with whom a predisposing mutation has been identified must communicated its related information on the risk of cancer and the ability to perform genetic analysis. It appears that this dissemination of information is not always optimal, as shown in figures from the National Cancer Institute joined the project; the purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests

Predisposition to Breast Cancer BRCA1 / BRCA2 and to HNPCC Colon : Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests

The intrafamilial disclosure rate assessed the number of relatives informed by the proband about the mutation (according to the proband) out of the number of relatives at risk of carrying the familial mutation. Relatives who were considered "at risk" were first, second, third or fourth-degree relatives, older than 18 years and related to the relevant side of the family or, if unknown, just related to the proband whatever the family side.

The relatives' genetic targeted testing uptake rate assessed the number of relatives considered by the proband to have taken up the genetic targeted testing out of the number of relatives informed by the proband. To assess the potential bias of the proband's perception of genetic targeted testing uptake by relatives, we compared the number of relatives who underwent genetic targeted testing according to the proband with the number of tests actually performed. This anonymous comparison was performed in a subset of the population within the geographic regional area of Montpellier where all analyses are centralized in a single laboratory. Probands were asked how many relatives living in the region underwent genetic testing and this number was compared with the information available from the University Laboratory of Montpellier.

University Hospital, Montpellier

Respiratory Tract (Lung and Bronchial) Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Antineoplastic Agents

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

All subjects will take olaparib by mouth twice per day until disease progression or unacceptable toxicity

ClinOmics

Raffit Hassan, M.D.

Background:

The drug olaparib may stop cancer cells from fixing damage to their deoxyribonucleic acid (DNA). It has been approved to treat certain cancers in people that were born with a mutation in the breast cancer (BRCA) gene. It has not been approved for treating mesothelioma. But some people with mesothelioma have mutations in a gene, BRCA1 Associated Protein 1 (BAP1) related to BRCA. Researchers want to see if olaparib can work in patients with mutations in this gene. They also want to see if works on mutations in other genes or patients without any mutations. They want to see if olaparib causes mesothelioma tumors to shrink.

Objective:

To study the effect of olaparib on mesothelioma.

Eligibility:

People ages 18 and older with malignant mesothelioma that has already been treated

Design:

Participants will be screened with

Sample of tumor tissue or fluid

Medical history

Physical exam

Blood, heart, and urine tests

Scans and x-rays

Participants will give blood and tissue samples. These will be genetically tested.

The study will be done in 21-day cycles.

Participants will take tables of the study drug 2 times each day. They will get information on what food and drugs to avoid during the study. They will get information about birth control. They will keep a diary of doses and symptoms.

Participants will have blood and urine tests and scans every few weeks.

Participants will be told any important genetic testing results.

Participants will stay in the study until their disease gets worse or the participant or their doctor chooses to stop it.

About 30 days after stopping the study drug, participants will have a follow-up visit. They will have a medical history, physical exam, blood tests, and scans.

Some participants will continue to have scans every 6 weeks.

...

Background:

* Malignant mesothelioma is an invasive and often fatal neoplasm that arises from mesothelium that lines several organs.
* Recent studies have identified germline mutations in the gene encoding breast cancer type 1 (BRCA1) associated protein-1 (BAP1) which can predispose to mesothelioma
* In addition to mesothelioma, germline BAP1 mutations confer increased susceptibility for the development of several other tumors including uveal melanoma, cutaneous melanoma, renal cell cancers and possibly other cancers
* In addition to BAP1, we found several novel germline variants that have previously not been associated with risk of developing mesothelioma.
* As evidenced by recent data derived from ovarian and prostate cancer patients, mutations in deoxyribonucleic acid (DNA) repair genes can define subgroups of cancer patients with distinct vulnerabilities to DNA damage response inhibitors.
* Olaparib is a Poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated
* Both established and patient derived mesothelioma cell lines with mutated DNA repair genes are sensitive to olaparib.

Objective:

-Determine the efficacy with respect to objective response rate of olaparib in patients with malignant mesothelioma based on somatic or germline mutation status of DNA repair genes

Eligibility:

* Patients must have progressive, histologically or cytologically confirmed malignant mesothelioma.
* Age greater than or equal to 18 years
* Patients must have received prior platinum and pemetrexed based therapies
* Adequate organ and bone marrow function

Design:

* This is a phase II, single center study of olaparib in subjects with malignant mesothelioma
* All subjects will take olaparib by mouth twice daily until disease progression or intolerable side effects
* Subjects will be assessed for safety (continuously) and efficacy (every 6 weeks)
* Subjects will be analyzed in 3 separate comparison groups according to their mutation status

  * Comparison Group 1: Patients with a germline mutation in DNA repair genes
  * Comparison Group 2: Patients with BAP1 somatic mutations
  * Comparison Group 3: Patients with neither germline mutations nor BAP 1 somatic mutations
* Up to 30 evaluable subjects will be enrolled

Olaparib in People With Malignant Mesothelioma

Phase II Study of Olaparib in Subjects With Malignant Mesothelioma

Number of participants overall who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.

Number of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.

Percentage of participants with germline deoxyribonucleic acid (DNA) repair mutation who experienced partial or complete response. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.

Percentage of subjects with neither germline DNA repair mutations nor somatic BAP1 mutations who experienced partial or complete response.Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Dose Limiting-toxicities (DLT's) is defined as

National Cancer Institute (NCI)

Principal Investigator

Data is grouped as specified per protocol.

Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes

Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes

Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations

Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations

Participants With no tumor tissue available for somatic mutation

Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations

Participants Not Classified Under Comparison Groups

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Canada

Region of Enrollment

Dr. Raffit Hassan

Partial Response

Complete Response

Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations

Participants with no tumor tissue available for somatic mutation

Number of Participants With an Objective Response

Per protocol, this outcome measure was only assessed in participants in Comparison Group 1.

Number of Participants With Germline Deoxyribonucleic Acid (DNA) Repair Mutation Who Experienced Partial or Complete Response.

Per protocol, this outcome measure was only assessed in participants in Comparison Group 2.

Percentage of Participants With Breast Cancer Type 1 Associated Protein-1 (BAP1) Somatic Mutations Who Experienced Partial or Complete Response.

Per protocol, this outcome measure was only assessed in participants in Comparison Group 3.

Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response.

Comparison Group 2 Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests	NCT03889171	Cancer Colorectal Canc... Breast Cancer Ovarian Cancer	Behaviour	18 Years -	University Hospital, Montpellier
Olaparib in People With Malignant Mesothelioma	NCT03531840	Mesothelioma	Olaparib ClinOmics	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Olaparib in People With Malignant Mesothelioma	NCT03531840	Mesothelioma	Olaparib ClinOmics	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Olaparib in People With Malignant Mesothelioma	NCT03531840	Mesothelioma	Olaparib ClinOmics	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for dna mismatch repair