A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial

NCT06497270 | Active Not Recruiting

• 1 other identifier: DISC-OVARY
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Selecting theca and granulosa cells from removed ovaries of BRCA1/2mut patients undergoing Risk-reducing salpingo-oophorectomy (RRSO) and developing a 3D bioprinted hormone-producing bioprosthetic model. If efficacy and tolerability are confirmed in vivo, this bioprosthetic model might be used to replace hormones' production in BRCA mutated patients undergoing prophylactic surgery.

Conditions

BRCA Mutation; Estrogen Deficiency; Surgical Menopause; Menopause Related Conditions; Menopause, Premature; Ovarian Cancer

Keywords

BRCA mutation; Surgical menopause; ovarian cancer prevention; estrogen deficiency

Outcome Measures

Primary Outcomes (1)

• oestrogens and progesterone's levels

  (Unit: pg/mL for both hormones)

  minumum 3 months

Study Arms (1)

BRCAmut patients

EXPERIMENTAL

germinal BRCA1/2 mutated (BRCAmut) patients undergoing risk reducing salpingo-oophorectomy whose ovaries will be used to select theca and granulosa cells for the 3D bioprinted device.

Procedure: Theca and Granulosa Cell Isolation

Interventions

Theca and Granulosa Cell Isolation PROCEDURE

These patients will receive standard procedure during the risk reducing surgery but their ovaries will be used to extract theca and granulosa cells which will be used for the 3D bioprinted device's realisation.

BRCAmut patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 18-40 years old;
• BRCA1/2 germline mutations;
• Completed childbearing;
• Willing to undergo RRSO;
• Negative final histological examination;
• No previous breast cancer.

You may not qualify if:

• Other malignancies;
• Final histological examination reporting malignant disease (any);
• Desire of fertility sparing.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Day Hospital Tumori Femminili, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS

Rome, 00168, Italy

Location

Related Publications (21)

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MeSH Terms

Conditions

Menopause, Premature; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Claudia Marchetti, Professor

  Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD PhD

Model Details: PILOT study

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 11, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)