Impact of Different BRCA1/2 Gene Variants on Response to Therapy and Prognosis of Ovarian Cancer

NCT06775470 | Recruiting

• 1 other identifier: IMBARCO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Identify any significant differences in terms of drug response and survival between the different possible alterations in the BRCA1/2 genes, in order to stratify ovarian cancer patients with a view to increasingly personalised and thus effective therapy.

Conditions

Ovarian Cancer

Keywords

BRCA1; BRCA2; PARP

Outcome Measures

Primary Outcomes (1)

• Differences in BRCA1/2 status for predictive response to chemotherapy

  The primary objective of the study is to clarify whether differences in the status of BRCA1/2 (presence/absence of germline and/or somatic) may be predictive in the response to chemotherapy and survival of patients with ovarian cancer.

  12 months

Secondary Outcomes (1)

• Differences in response to chemotherapy based on BRCA variant

  12 months

Interventions

Patients must have been diagnosed with ovarian cancer and be BRCA positive DIAGNOSTIC_TEST

Patients must have been diagnosed with ovarian carcinoma by 31/12/2021, have undergone BRCA testing at the UOC of Medical Genetics of the IRCCS AOU of Bologna Policlinico S. Orsola by 31/12/2021 and have been taken on for follow-up and/or treatment at the Medical Oncology - Zamagni and/or Gynaecological Oncology - De Iaco of the IRCCS Azienda Ospedaliero-Universitaria (AOU) of Bologna for a period of time of at least 1 year and by 31/12/2021 and for a minimum period of 6 months.

BRCA1 and BRCA2 positive, and be affected by Ovarian Cancer DIAGNOSTIC_TEST

Patients must have been diagnosed with ovarian carcinoma by 31/12/2021, have undergone BRCA testing at the UOC of Medical Genetics of the IRCCS AOU of Bologna Policlinico S. Orsola by 31/12/2021 and have been taken on for follow-up and/or treatment at the Medical Oncology - Zamagni and/or Gynaecological Oncology - De Iaco of the IRCCS Azienda Ospedaliero-Universitaria (AOU) of Bologna for a period of time of at least 1 year and by 31/12/2021 and for a minimum period of 6 months.

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From 2012 to the end of 2021, 869 patients underwent BRCA testing at the UOC of Medical Genetics of the IRCCS AOU of Bologna Policlinico S.Orsola 869 patients with CO, almost all of whom have given informed consent to the acquisition of clinical documentation relating to their case and to the use of their data for scientific purposes and about half of them were taken on for a period of at least 1 year at the Medical Oncology - Zamagni and/or the Gynaecological Oncology - De Iaco. The investigators estimated a sample of about 300 patients.

You may qualify if:

• ovarian cancer diagnosis by 31/12/2021;
• BRCA test at the UOC of Medical Genetics of the IRCCS AOU of Bologna Policlinico S.Orsola by 31/12/2021;
• follow-up and/or treatment at Medical Oncology and/or Gynaecological Oncology of the IRCCS Azienda Ospedaliero-Universitaria (AOU) of Bologna for a period of time of at least 1 year and by 31/12/2021 and for a minimum period of 6 months

You may not qualify if:

• ovarian carcinoma of 'mucinous' or 'borderline' histotype.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Genes, BRCA1

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Genes, Tumor Suppressor; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Genes, Recessive

Study Officials

• Daniela Turchetti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Turchetti, MD

CONTACT

+390512143694; daniela.turchetti@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 15, 2025
• Study Start: July 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)