BRCA MutationDISC-OVARYNCT06497270
A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial
A study testing Theca and Granulosa Cell Isolation in people with BRCA Mutation and Estrogen Deficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- BRCA Mutation, Estrogen Deficiency, Surgical Menopause
- What is being tested?
- Theca and Granulosa Cell Isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 18-40 years old;
- BRCA1/2 germline mutations;
- Completed childbearing;
- Willing to undergo RRSO;
- Negative final histological examination;
- No previous breast cancer.
Who cannot join
- Other malignancies;
- Final histological examination reporting malignant disease (any);
- Desire of fertility sparing.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Day Hospital Tumori Femminili, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS
Rome, 00168
About this study
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.
Read the detailed description
Background and Rationale Women carrying germline BReast CAncer gene (BRCA) 1/2 mutations have an increased lifetime risk of breast and ovarian cancers (72% and 44% for BRCA1 and 69% and 17% for BRCA2, respectively). Risk-reducing salpingo-oophorectomy (RRSO) by the age of 40 (postponable to age of 45 for BRCA2mut) is the standard of care in ovarian cancer risk reduction (about 80%). Although potentially lifesaving, RRSO may negatively affect quality of life and impair long-term health (cardiovascular disease, osteoporosis and impairment of immune response).
To overcome these side effects, hormone replacement therapy (HRT) is crucial but remains a major concern, especially due to its negative effects (potential breast cancer risk, thromboembolic events) and, overall, due to the long-term safety lack of data. Synthetic and animal-derived hormones seem to be associated with breast cancer risk. Although breast cancer risk is lower for bioidentical hormones (i.e. estriol), data continue to be discordant. Several evidence still sustain estriol's impact on breast cancer (especially for lobular histotype; OR 2.0, 95% CI 1.3-3.2) and endometrial disease (endometrial cancer: OR 3.0, 95% CI 2.0-4.4 and endometrial atypical hyperplasia: OR 8.3, 95% CI 4.0-17.4, respectively). Furthermore, estriol's efficacy on cardiovascular disease and osteoporosis is still unclear when compared to other estrogen compounds. Side effects of estriol therapy may include breast tenderness, nausea, bloating, mood changes, headache, and vaginal bleeding or spotting. Moreover, all the HRT's administration routes (oral, transdermal, and vaginal) need daily/frequent assumption, thus compliance of the patients is essential and adherence to long-term therapy in developed countries is reported around 50% with a high risk of forgetfulness or discontinuation. Each route also has specific disadvantages (i.e. the risk of thromboembolism in the oral one). Finally, HRT may influence other hormones' production: it increases T4 dosage requirements of women being treated for primary hypothyroidism as well as alter the pituitary-thyroid axis in euthyroid women. While for cortisol level findings are still inconsistent, hormone exogenous intake does not permit to follow the daily hormonal fluctuation. Aging and hypoestrogenism, in postmenopausal women, determine immune system changes which may play a crucial role in the development of postmenopausal diseases (diabetes or atherosclerosis) and may be negatively influenced by HRT. Preliminary data of a recent MITO group survey revealed that only 70% of gynecologists recommend HRT after RRSO due to oncological safety concerns and low women's requests (more than 70% of cases were oral prescriptions, while only 24% preferred local administration).
In conclusion, for some women, the concern of menopause risks act as a deterrent for a lifesaving procedure (RRSO). In this scenario, it is fundamental to provide a new strategy for BRCA mutated patients, in order to reduce menopausal drawbacks without exposing participants to a higher breast cancer risk, reproducing the physiological hormonal rhythm without compliance issue. The 3D bioprinted hormone-producing model from patients' own autologous cells could meet this need.
HYPOTHESIS The investigators hypothesize to select theca and granulosa cells from removed ovaries of BRCA1/2mut patients undergoing RRSO, avoiding the epithelial ones at risk of developing cancer, and use those cells to develop a 3D bioprinted hormone-producing bioprosthetic model in order to replace patients' own production.
AIMS Primary endpoint: Restore normal estrogen and progesterone serum level in participants undergoing RRSO by the 3D bioprinted hormone-producing model's implant.
EXPERIMENTAL DESIGN No study has previously investigated the feasibility of 3D bioprinted hormone-producing model, hence this configures as a pilot study which, as such, does not need any formal sample size calculation.
The proposed research project aims to select theca and granulosa cells from patients' removed ovaries, combine them with different ratios of extracted mesenchymal cells; print them onto the prosthetic model scaffolds and assess the hormone production.
IMPACT ON CANCER The results of the pilot project will provide a 3D bioprinted model able to produce estrogens and progesterone in vitro. If functionality is confirmed in vivo, the model might be used in BRCA mutated patients allowing them to avoid surgery induced menopause's side effects. Specifically, a 3D bioprinted hormone-producing bioprosthetic model would provide patients with a viable alternative to surgery-induced menopause and traditional HRT.
- Conditions
- BRCA Mutation, Estrogen Deficiency, Surgical Menopause, Menopause Related Conditions, Menopause, Premature, Ovarian Cancer
- Being tested
- Theca and Granulosa Cell Isolation
- Keywords
- BRCA mutation, Surgical menopause, ovarian cancer prevention, estrogen deficiency
- Medical subject headings
- Menopause, Premature, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theca and Granulosa Cell IsolationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Theca and Granulosa Cell Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
oestrogens and progesterone's levels
(Unit: pg/mL for both hormones)
Measured: minumum 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start10 Oct 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for BRCA MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PILOT study
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCHETTI CLAUDIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Claudia Marchetti, Professor, Principal investigator, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497270
- Sponsor's protocol ID
- DISC-OVARY
- Acronym
- DISC-OVARY
- Status last verified
- Oct 2024
- First submitted
- 26 Jun 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antoniou A, Pharoah PD, Narod S, Risch HA, Eyfjord JE, Hopper JL, Loman N, Olsson H, Johannsson O, Borg A, Pasini B, Radice P, Manoukian S, Eccles DM, Tang N, Olah E, Anton-Culver H, Warner E, Lubinski J, Gronwald J, Gorski B, Tulinius H, Thorlacius S, Eerola H, Nevanlinna H, Syrjakoski K, Kallioniemi OP, Thompson D, Evans C, Peto J, Lalloo F, Evans DG, Easton DF. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case Series unselected for family history: a combined analysis of 22 studies. Am J Hum Genet. 2003 May;72(5):1117-30. doi: 10.1086/375033. Epub 2003 Apr 3.
PubMed 12677558Gabaldo Barrios X, Sarabia Meseguer MD, Marin Vera M, Sanchez Bermudez AI, Macias Cerrolaza JA, Sanchez Henarejos P, Zafra Poves M, Garcia Hernandez MR, Cuevas Tortosa E, Aliaga Bano A, Castillo Guardiola V, Martinez Hernandez P, Tovar Zapata I, Martinez Barba E, Ayala de la Pena F, Alonso Romero JL, Noguera Velasco JA, Ruiz Espejo F. Molecular characterization and clinical interpretation of BRCA1/BRCA2 variants in families from Murcia (south-eastern Spain) with hereditary breast and ovarian cancer: clinical-pathological features in BRCA carriers and non-carriers. Fam Cancer. 2017 Oct;16(4):477-489. doi: 10.1007/s10689-017-9985-x.
PubMed 28477318Marchetti C, De Felice F, Palaia I, Perniola G, Musella A, Musio D, Muzii L, Tombolini V, Panici PB. Risk-reducing salpingo-oophorectomy: a meta-analysis on impact on ovarian cancer risk and all cause mortality in BRCA 1 and BRCA 2 mutation carriers. BMC Womens Health. 2014 Dec 12;14:150. doi: 10.1186/s12905-014-0150-5.
PubMed 25494812Rocca WA, Grossardt BR, de Andrade M, Malkasian GD, Melton LJ 3rd. Survival patterns after oophorectomy in premenopausal women: a population-based cohort study. Lancet Oncol. 2006 Oct;7(10):821-8. doi: 10.1016/S1470-2045(06)70869-5.
PubMed 17012044Madalinska JB, Hollenstein J, Bleiker E, van Beurden M, Valdimarsdottir HB, Massuger LF, Gaarenstroom KN, Mourits MJ, Verheijen RH, van Dorst EB, van der Putten H, van der Velden K, Boonstra H, Aaronson NK. Quality-of-life effects of prophylactic salpingo-oophorectomy versus gynecologic screening among women at increased risk of hereditary ovarian cancer. J Clin Oncol. 2005 Oct 1;23(28):6890-8. doi: 10.1200/JCO.2005.02.626. Epub 2005 Aug 29.
PubMed 16129845Gaba F, Blyuss O, Chandrasekaran D, Osman M, Goyal S, Gan C, Izatt L, Tripathi V, Esteban I, McNicol L, Ragupathy K, Crawford R, Evans DG, Legood R, Menon U, Manchanda R. Attitudes towards risk-reducing early salpingectomy with delayed oophorectomy for ovarian cancer prevention: a cohort study. BJOG. 2021 Mar;128(4):714-726. doi: 10.1111/1471-0528.16424. Epub 2020 Aug 16.
PubMed 32803845Kumru S, Godekmerdan A, Yilmaz B. Immune effects of surgical menopause and estrogen replacement therapy in peri-menopausal women. J Reprod Immunol. 2004 Aug;63(1):31-8. doi: 10.1016/j.jri.2004.02.001.
PubMed 15284002Rott H. Prevention and treatment of venous thromboembolism during HRT: current perspectives. Int J Gen Med. 2014 Sep 1;7:433-40. doi: 10.2147/IJGM.S46310. eCollection 2014.
PubMed 25210472Bakken K, Alsaker E, Eggen AE, Lund E. Hormone replacement therapy and incidence of hormone-dependent cancers in the Norwegian Women and Cancer study. Int J Cancer. 2004 Oct 20;112(1):130-4. doi: 10.1002/ijc.20389.
PubMed 15305384Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. doi: 10.3810/pgm.2009.01.1949.
PubMed 19179815Rosenberg LU, Magnusson C, Lindstrom E, Wedren S, Hall P, Dickman PW. Menopausal hormone therapy and other breast cancer risk factors in relation to the risk of different histological subtypes of breast cancer: a case-control study. Breast Cancer Res. 2006;8(1):R11. doi: 10.1186/bcr1378. Epub 2006 Feb 17.
PubMed 16507159Weiderpass E, Baron JA, Adami HO, Magnusson C, Lindgren A, Bergstrom R, Correia N, Persson I. Low-potency oestrogen and risk of endometrial cancer: a case-control study. Lancet. 1999 May 29;353(9167):1824-8. doi: 10.1016/S0140-6736(98)10233-7.
PubMed 10359406Furness S, Roberts H, Marjoribanks J, Lethaby A. Hormone therapy in postmenopausal women and risk of endometrial hyperplasia. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD000402. doi: 10.1002/14651858.CD000402.pub4.
PubMed 22895916Faulkner DL, Young C, Hutchins D, McCollam JS. Patient noncompliance with hormone replacement therapy: a nationwide estimate using a large prescription claims database. Menopause. 1998 Winter;5(4):226-9.
PubMed 9872489Skouby SO, Barlow D, Samsioe G, Gompel A, Pines A, Al-Azzawi F, Graziottin A, Hudita D, Rozenberg S; European Menopause and Andropause Society (EMAS). Climacteric medicine: European Menopause and Andropause Society (EMAS) statements on postmenopausal hormonal therapy. Maturitas. 2004 May 28;48(1):19-25. doi: 10.1016/j.maturitas.2004.03.003.
PubMed 15223104
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3D Bioprinted Hormone-producing Model for BRCA Mutated Patients After Risk Reducing Surgery: the DISC-OVARY Trial
- ClinicalTrials.gov ID
- NCT06497270
- Acronym / sponsor ID
- DISC-OVARY / DISC-OVARY
- Conditions
- BRCA Mutation, Estrogen Deficiency, Surgical Menopause, Menopause Related Conditions, Menopause, Premature, Ovarian Cancer
- Keywords
- BRCA mutation, Surgical menopause, ovarian cancer prevention, estrogen deficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale Women carrying germline BReast CAncer gene (BRCA) 1/2 mutations have an increased lifetime risk of breast and ovarian cancers (72% and 44% for BRCA1 and 69% and 17% for BRCA2, respectively). Risk-reducing salpingo-oophorectomy (RRSO) by the age of 40 (postponable to age of 45 for BRCA2mut) is the standard of care in ovarian cancer risk reduction (about 80%). Although potentially lifesaving, RRSO may negatively affect quality of life and impair long-term health (cardiovascular disease, osteoporosis and impairment of immune response).
To overcome these side effects, hormone replacement therapy (HRT) is crucial but remains a major concern, especially due to its negative effects (potential breast cancer risk, thromboembolic events) and, overall, due to the long-term safety lack of data. Synthetic and animal-derived hormones seem to be associated with breast cancer risk. Although breast cancer risk is lower for bioidentical hormones (i.e. estriol), data continue to be discordant. Several evidence still sustain estriol's impact on breast cancer (especially for lobular histotype; OR 2.0, 95% CI 1.3-3.2) and endometrial disease (endometrial cancer: OR 3.0, 95% CI 2.0-4.4 and endometrial atypical hyperplasia: OR 8.3, 95% CI 4.0-17.4, respectively). Furthermore, estriol's efficacy on cardiovascular disease and osteoporosis is still unclear when compared to other estrogen compounds. Side effects of estriol therapy may include breast tenderness, nausea, bloating, mood changes, headache, and vaginal bleeding or spotting. Moreover, all the HRT's administration routes (oral, transdermal, and vaginal) need daily/frequent assumption, thus compliance of the patients is essential and adherence to long-term therapy in developed countries is reported around 50% with a high risk of forgetfulness or discontinuation. Each route also has specific disadvantages (i.e. the risk of thromboembolism in the oral one). Finally, HRT may influence other hormones' production: it increases T4 dosage requirements of women being treated for primary hypothyroidism as well as alter the pituitary-thyroid axis in euthyroid women. While for cortisol level findings are still inconsistent, hormone exogenous intake does not permit to follow the daily hormonal fluctuation. Aging and hypoestrogenism, in postmenopausal women, determine immune system changes which may play a crucial role in the development of postmenopausal diseases (diabetes or atherosclerosis) and may be negatively influenced by HRT. Preliminary data of a recent MITO group survey revealed that only 70% of gynecologists recommend HRT after RRSO due to oncological safety concerns and low women's requests (more than 70% of cases were oral prescriptions, while only 24% preferred local administration).
In conclusion, for some women, the concern of menopause risks act as a deterrent for a lifesaving procedure (RRSO). In this scenario, it is fundamental to provide a new strategy for BRCA mutated patients, in order to reduce menopausal drawbacks without exposing participants to a higher breast cancer risk, reproducing the physiological hormonal rhythm without compliance issue. The 3D bioprinted hormone-producing model from patients' own autologous cells could meet this need.
HYPOTHESIS The investigators hypothesize to select theca and granulosa cells from removed ovaries of BRCA1/2mut patients undergoing RRSO, avoiding the epithelial ones at risk of developing cancer, and use those cells to develop a 3D bioprinted hormone-producing bioprosthetic model in order to replace patients' own production.
AIMS Primary endpoint: Restore normal estrogen and progesterone serum level in participants undergoing RRSO by the 3D bioprinted hormone-producing model's implant.
EXPERIMENTAL DESIGN No study has previously investigated the feasibility of 3D bioprinted hormone-producing model, hence this configures as a pilot study which, as such, does not need any formal sample size calculation.
The proposed research project aims to select theca and granulosa cells from patients' removed ovaries, combine them with different ratios of extracted mesenchymal cells; print them onto the prosthetic model scaffolds and assess the hormone production.
IMPACT ON CANCER The results of the pilot project will provide a 3D bioprinted model able to produce estrogens and progesterone in vitro. If functionality is confirmed in vivo, the model might be used in BRCA mutated patients allowing them to avoid surgery induced menopause's side effects. Specifically, a 3D bioprinted hormone-producing bioprosthetic model would provide patients with a viable alternative to surgery-induced menopause and traditional HRT.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PILOT study
| Arm | Type | Receives |
|---|---|---|
| BRCAmut patients | Experimental | Procedure: Theca and Granulosa Cell Isolationgerminal 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women between 18-40 years old;
- BRCA1/2 germline mutations;
- Completed childbearing;
- Willing to undergo RRSO;
- Negative final histological examination;
Key exclusion criteria (3 listed)
- Other malignancies;
- Final histological examination reporting malignant disease (any);
- Desire of fertility sparing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theca and Granulosa Cell IsolationThese 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. | Procedure or surgery | BRCAmut patients |
Primary outcome
oestrogens and progesterone's levels
Time frame: minumum 3 months
(Unit: pg/mL for both hormones)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 12677558Antoniou A, Pharoah PD, Narod S, Risch HA, Eyfjord JE, Hopper JL, Loman N, Olsson H, Johannsson O, Borg A, Pasini B, Radice P, Manoukian S, Eccles DM, Tang N, Olah E, Anton-Culver H, Warner E, Lubinski J, Gronwald J, Gorski B, Tulinius H, Thorlacius S, Eerola H, Nevanlinna H, Syrjakoski K, Kallioniemi OP, Thompson D, Evans C, Peto J, Lalloo F, Evans DG, Easton DF. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case Series unselected for family history: a combined analysis of 22 studies. Am J Hum Genet. 2003 May;72(5):1117-30. doi: 10.1086/375033. Epub 2003 Apr 3.
- Background: PubMed 28477318Gabaldo Barrios X, Sarabia Meseguer MD, Marin Vera M, Sanchez Bermudez AI, Macias Cerrolaza JA, Sanchez Henarejos P, Zafra Poves M, Garcia Hernandez MR, Cuevas Tortosa E, Aliaga Bano A, Castillo Guardiola V, Martinez Hernandez P, Tovar Zapata I, Martinez Barba E, Ayala de la Pena F, Alonso Romero JL, Noguera Velasco JA, Ruiz Espejo F. Molecular characterization and clinical interpretation of BRCA1/BRCA2 variants in families from Murcia (south-eastern Spain) with hereditary breast and ovarian cancer: clinical-pathological features in BRCA carriers and non-carriers. Fam Cancer. 2017 Oct;16(4):477-489. doi: 10.1007/s10689-017-9985-x.
- Background: PubMed 25494812Marchetti C, De Felice F, Palaia I, Perniola G, Musella A, Musio D, Muzii L, Tombolini V, Panici PB. Risk-reducing salpingo-oophorectomy: a meta-analysis on impact on ovarian cancer risk and all cause mortality in BRCA 1 and BRCA 2 mutation carriers. BMC Womens Health. 2014 Dec 12;14:150. doi: 10.1186/s12905-014-0150-5.
- Background: PubMed 17012044Rocca WA, Grossardt BR, de Andrade M, Malkasian GD, Melton LJ 3rd. Survival patterns after oophorectomy in premenopausal women: a population-based cohort study. Lancet Oncol. 2006 Oct;7(10):821-8. doi: 10.1016/S1470-2045(06)70869-5.
- Background: PubMed 16129845Madalinska JB, Hollenstein J, Bleiker E, van Beurden M, Valdimarsdottir HB, Massuger LF, Gaarenstroom KN, Mourits MJ, Verheijen RH, van Dorst EB, van der Putten H, van der Velden K, Boonstra H, Aaronson NK. Quality-of-life effects of prophylactic salpingo-oophorectomy versus gynecologic screening among women at increased risk of hereditary ovarian cancer. J Clin Oncol. 2005 Oct 1;23(28):6890-8. doi: 10.1200/JCO.2005.02.626. Epub 2005 Aug 29.
- Background: PubMed 32803845Gaba F, Blyuss O, Chandrasekaran D, Osman M, Goyal S, Gan C, Izatt L, Tripathi V, Esteban I, McNicol L, Ragupathy K, Crawford R, Evans DG, Legood R, Menon U, Manchanda R. Attitudes towards risk-reducing early salpingectomy with delayed oophorectomy for ovarian cancer prevention: a cohort study. BJOG. 2021 Mar;128(4):714-726. doi: 10.1111/1471-0528.16424. Epub 2020 Aug 16.
- Background: PubMed 15284002Kumru S, Godekmerdan A, Yilmaz B. Immune effects of surgical menopause and estrogen replacement therapy in peri-menopausal women. J Reprod Immunol. 2004 Aug;63(1):31-8. doi: 10.1016/j.jri.2004.02.001.
- Background: PubMed 25210472Rott H. Prevention and treatment of venous thromboembolism during HRT: current perspectives. Int J Gen Med. 2014 Sep 1;7:433-40. doi: 10.2147/IJGM.S46310. eCollection 2014.
- Background: PubMed 15305384Bakken K, Alsaker E, Eggen AE, Lund E. Hormone replacement therapy and incidence of hormone-dependent cancers in the Norwegian Women and Cancer study. Int J Cancer. 2004 Oct 20;112(1):130-4. doi: 10.1002/ijc.20389.
- Background: PubMed 19179815Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. doi: 10.3810/pgm.2009.01.1949.
- Background: PubMed 16507159Rosenberg LU, Magnusson C, Lindstrom E, Wedren S, Hall P, Dickman PW. Menopausal hormone therapy and other breast cancer risk factors in relation to the risk of different histological subtypes of breast cancer: a case-control study. Breast Cancer Res. 2006;8(1):R11. doi: 10.1186/bcr1378. Epub 2006 Feb 17.
- Background: PubMed 10359406Weiderpass E, Baron JA, Adami HO, Magnusson C, Lindgren A, Bergstrom R, Correia N, Persson I. Low-potency oestrogen and risk of endometrial cancer: a case-control study. Lancet. 1999 May 29;353(9167):1824-8. doi: 10.1016/S0140-6736(98)10233-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Marchetti, Professor principal investigator
Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theca and Granulosa Cell Isolation in people with BRCA Mutation and Estrogen Deficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oestrogens and progesterone's levels (time frame: minumum 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06497270, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.