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Ovarian CancerNCT07532434

A Bidirectional Cohort Study on Prophylactic Resection Surgery in Populations at Moderate-to-High Risk for Hereditary Ovarian Cancer

An observational study of Ovarian Cancer and Breast Cancer, run by Peking University Third Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this multi-center observational study is to learn about the effectiveness and safety of different prophylactic (preventive) surgical options in women at moderate-to-high genetic risk for hereditary ovarian cancer (HOC). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Breast Cancer
How many people
480 participants
Where
1 siteChina
Study dates
30 Sep 2025to 30 Sep 2035
How long will I take part?
15 Years
Phase
Observational
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: This study targets Chinese women at moderate-to-high genetic risk for hereditary ovarian cancer (HOC). The population includes documented carriers of pathogenic or likely pathogenic (P/LP) germline mutations in high-risk susceptibility genes, primarily BRCA1 and BRCA2, as well as other HRR-related genes such as RAD51C, RAD51D, BRIP1, and PALB2. The population encompasses both premenopausal and postmenopausal women seeking individualized risk-management strategies.

Who may be able to join

  • Gender: Female. Age: 18 years or older at the time of enrollment.Genetic Risk: Documented carriers of pathogenic or likely pathogenic germline mutations in high-risk ovarian cancer susceptibility genes (including BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2). Data Availability: Willing to provide informed consent and allow access to clinical records, genetic testing reports, and follow-up data (bidirectional cohort). Psychosocial Status: Ability to complete quality of life and psychological assessment scales (e.g., GCS, SF-36, FSFI).

Who cannot join

  • Prior Malignancy: History of ovarian, fallopian tube, or primary peritoneal cancer prior to the baseline intervention. Synchronous Malignancy: Diagnosis of any other advanced-stage malignancy. Inability to Follow-up: Significant psychological, social, or geographical factors that would prevent regular long-term follow-up (3 years). Previous Extensive Pelvic Surgery: History of extensive pelvic surgery that precludes the feasibility of laparoscopic prophylactic salpingectomy or oophorectomy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Associate Chief Physician/Associate Consultant, Doctor contact

18610689868

yuanli@bjmu.edu.cn

China1 site, 1 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Associate Chief Physician/Associate Consultant, Doctor, 18610689868, yuanli@bjmu.edu.cn

    Recruiting

Other trials in China

About this study

The goal of this multi-center observational study is to learn about the effectiveness and safety of different prophylactic (preventive) surgical options in women at moderate-to-high genetic risk for hereditary ovarian cancer (HOC).

The main questions it aims to answer are:

Read more

Does individualized prophylactic surgery (such as removing fallopian tubes now and delaying ovary removal) effectively reduce the risk of developing ovarian cancer compared to standard care or close monitoring?

How do these different surgical interventions affect a woman's ovarian function and quality of life?

What Participants Will Do:

Participants who are healthy carriers of specific genetic mutations (such as BRCA1/2, RAD51C/D, etc.) will be followed in a bidirectional cohort. Depending on the medical care and surgical path they choose with their doctors (Standard RRSO, Delayed Oophorectomy, or Close Monitoring), researchers will collect their clinical data, surgical pathology results, and follow-up information regarding cancer incidence and quality of life for 3 years.

Read the detailed description
  1. Study Rationale and Background Epithelial ovarian cancer (OC) remains a significant health burden in China, with high mortality due to the lack of effective early screening methods. Approximately 20% of OC cases are attributed to hereditary factors, primarily germline pathogenic variants in BRCA1/2 and other homologous recombination repair (HRR) genes. The traditional standard for risk reduction is Risk-Reducing Salpingo-Oophorectomy (RRSO). However, the "dualistic model" of ovarian carcinogenesis suggests that a significant proportion of high-grade serous carcinomas (HGSC) originate as Serous Tubal Intraepithelial Carcinoma (STIC) in the fallopian tubes. This provides a biological rationale for Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO, also known as RS-DO). This study aims to establish a Chinese bidirectional cohort to evaluate the effectiveness, safety, and impact on quality of life (QoL) of individualized prophylactic surgical strategies.
  2. Study Design and Cohort Construction This is a bidirectional (combined retrospective and prospective) cohort study. Retrospective Component: Data will be extracted from clinical records dating back to 2020 for individuals who meet the high-risk genetic criteria and have previously undergone risk-reducing surgery or entered clinical monitoring. Prospective Component: Eligible participants will be recruited and followed for a minimum of 5 years. Participants are categorized into three cohorts based on the clinical intervention received: RRSO Group: Concomitant removal of fallopian tubes and ovaries. RS-DO Group: Initial salpingectomy followed or not followed by delayed oophorectomy (typically at age 45-50 or based on mutation type). Close Monitoring Group: For those declining surgery, intensive surveillance via transvaginal ultrasound and serum CA-125/HE4 testing.
  3. Quality Assurance and Registry Procedures To ensure the highest data integrity, the following procedures are implemented: Centralized Pathology Review: All surgical specimens from prophylactic procedures must undergo the SEE-FIM (Sectioning and Extensively Examining the FIMbria) protocol to detect occult STIC or early invasive carcinoma. Data Validation: An Electronic Data Capture (EDC) system is utilized with automated data checks for range, consistency, and logical errors. Source Data Verification (SDV): Regular on-site or remote audits will be conducted on 20% of the registry entries to verify accuracy against primary medical records and genetic testing reports. Data Dictionary: All variables are predefined in a comprehensive data dictionary. Genetic variants are classified according to the American College of Medical Genetics and Genomics (ACMG) guidelines. Clinical complications are graded using the Clavien-Dindo classification.
  4. Statistical Analysis Plan (SAP) Sample Size: Based on the estimated incidence of OC in the Chinese high-risk population, the study aims to enroll approximately 480 participants (160 per arm) to provide sufficient power (80%) for survival analysis. Primary Endpoint Analysis: The cumulative incidence of ovarian, fallopian tube, and peritoneal cancer will be estimated using the Kaplan-Meier method. Differences between intervention groups will be compared using the Log-rank test and Cox Proportional Hazards Models, adjusting for age, parity, and specific mutation types (e.g., BRCA1 vs. BRCA2 vs. RAD51C/D). Secondary Endpoint Analysis: Changes in menopausal symptoms and sexual function scores (GCS, SF-36, FSFI) will be analyzed using Repeated Measures ANOVA (RM-ANOVA) or ANCOVA to adjust for baseline differences and hormone replacement therapy (HRT) use. Missing Data: A multiple imputation approach will be used for missing covariates, while sensitivity analysis will be performed to assess the impact of loss to follow-up.
  5. Standard Operating Procedures (SOPs)

The registry operates under standardized protocols for:

Standardized pre-test and post-test genetic counseling.

Uniform surgical techniques for salpingectomy and oophorectomy.

Standardized follow-up intervals (every 6-12 months).

Adverse event reporting and management of unexpected pathological findings (STIC).

Keywords
Hereditary Ovarian Cancer (HOC), BRCA1/2 Mutation Carriers, Risk-Reducing Salpingo-Oophorectomy (RRSO), Bidirectional Cohort Study, Risk-Reducing Salpingo-Oophorectomy（RRSO）
Medical subject headings
Ovarian Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07532434
Study groupRoleWhat they receive
Label 1: Standard RRSO Group. Label 2: Individualized RS-DO Group. Label 3: Close Monitoring GroupDescription of Label 1: Participants undergoing concurrent bilateral salpingo-oophorectomy per guidelines. Description of Label 2: Participants undergoing salpingectomy with delayed oophorectomy to preserve hormones.Description of Label 3: Participants declining surgery and choosing regular ultrasound and CA-125 surveillance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Ovarian Cancer

    The primary efficacy endpoint is the development of histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer among high-risk mutation carriers in different intervention groups.

    Measured: From the date of enrollment/surgery up to 15 years.

Secondary outcomes (4)

  1. Incidence of Breast Cancer

    Occurrence of new-onset breast cancer during the follow-up period, particularly for BRCA1/2 mutation carriers.

    Measured: From the date of enrollment up to 15 years.

  2. Incidence of Serous Tubal Intraepithelial Carcinoma (STIC)

    Frequency of STIC or occult invasive carcinoma detected in the surgical specimens of the fallopian tubes, examined using the standardized SEE-FIM pathological protocol.

    Measured: At the time of prophylactic surgery (approx. 1 day)

  3. Comprehensive Assessment of Quality of Life and Menopausal Symptoms

    A multi-dimensional evaluation of the participants' physical and endocrine-related health status using Greene Climacteric Scale (GCS), SF-36 Health Survey and other scales.

    Measured: Baseline, 1 month, 6 months and 1 year post-enrollment.

  4. Evaluation of Psychological Distress

    An assessment of the psychosocial impact of prophylactic surgery and cancer-related anxiety using Cancer Worry Scale (CWS), Female Sexual Distress Scale (FSDS) and other scales.

    Measured: Baseline, 1 month, 6 months and 1 year post-enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study start30 Sep 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
480 participants (estimated)
Target duration
15 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07532434
Sponsor's protocol ID
M20250883
Status last verified
Feb 2026
First submitted
8 Apr 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kuchenbaecker KB, Hopper JL, Barnes DR, Phillips KA, Mooij TM, Roos-Blom MJ, Jervis S, van Leeuwen FE, Milne RL, Andrieu N, Goldgar DE, Terry MB, Rookus MA, Easton DF, Antoniou AC; BRCA1 and BRCA2 Cohort Consortium; McGuffog L, Evans DG, Barrowdale D, Frost D, Adlard J, Ong KR, Izatt L, Tischkowitz M, Eeles R, Davidson R, Hodgson S, Ellis S, Nogues C, Lasset C, Stoppa-Lyonnet D, Fricker JP, Faivre L, Berthet P, Hooning MJ, van der Kolk LE, Kets CM, Adank MA, John EM, Chung WK, Andrulis IL, Southey M, Daly MB, Buys SS, Osorio A, Engel C, Kast K, Schmutzler RK, Caldes T, Jakubowska A, Simard J, Friedlander ML, McLachlan SA, Machackova E, Foretova L, Tan YY, Singer CF, Olah E, Gerdes AM, Arver B, Olsson H. Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers. JAMA. 2017 Jun 20;317(23):2402-2416. doi: 10.1001/jama.2017.7112.

    PubMed 28632866

  • Lukey A, Howard AF, Mei AJ, Law MR, Huntsman D, Pearce CL, Meza R, Hanley GE. Risk-reducing salpingectomy: considerations from an OBGYN perspective. BMC Cancer. 2025 Jun 6;25(1):1011. doi: 10.1186/s12885-025-14384-6.

    PubMed 40481395

  • Leblanc E, Narducci F, Ferron G, Mailliez A, Charvolin JY, Houssein EH, Guyon F, Fourchotte V, Lambaudie E, Crouzet A, Fouche Y, Gouy S, Collinet P, Caquant F, Pomel C, Golfier F, Vaini-Cowen V, Fournier I, Salzet M, Tresch E, Probst A, Lemaire AS, Deley ML, Hudry D. Prophylactic Radical Fimbriectomy with Delayed Oophorectomy in Women with a High Risk of Developing an Ovarian Carcinoma: Results of a Prospective National Pilot Study. Cancers (Basel). 2023 Feb 10;15(4):1141. doi: 10.3390/cancers15041141.

    PubMed 36831483

  • Sia J, Lane EF, Fierheller CT, Oxley S, Kalra A, Sideris M, Wei X, Mansour L, Idahl A, Fraser H, Ganesan S, Deshmukh P, Ganesan R, Hanson H, Saridogan E, Hamed H, McCluggage WG, Legood R, Sasieni P, Evans DG, Menon U, Brentnall A, Manchanda R; PROTECTOR team. Estimands for Clinical Effectiveness of Risk-Reducing Early Salpingectomy in Women With High Risk of Ovarian Cancer. JAMA Netw Open. 2025 Sep 2;8(9):e2532195. doi: 10.1001/jamanetworkopen.2025.32195.

    PubMed 40956577

  • Steenbeek MP, van Bommel MHD, intHout J, Peterson CB, Simons M, Roes KCB, Kets M, Norquist BM, Swisher EM, Hermens RPMG; TUBA-WISP II consortium; Lu KH, de Hullu JA. TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol. Int J Gynecol Cancer. 2023 Jun 5;33(6):982-987. doi: 10.1136/ijgc-2023-004377.

    PubMed 37045546

  • Steenbeek MP, Harmsen MG, Hoogerbrugge N, de Jong MA, Maas AHEM, Prins JB, Bulten J, Teerenstra S, van Bommel MHD, van Doorn HC, Mourits MJE, van Beurden M, Zweemer RP, Gaarenstroom KN, Slangen BFM, Brood-van Zanten MMA, Vos MC, Piek JMJ, van Lonkhuijzen LRCW, Apperloo MJA, Coppus SFPJ, Massuger LFAG, IntHout J, Hermens RPMG, de Hullu JA. Association of Salpingectomy With Delayed Oophorectomy Versus Salpingo-oophorectomy With Quality of Life in BRCA1/2 Pathogenic Variant Carriers: A Nonrandomized Controlled Trial. JAMA Oncol. 2021 Aug 1;7(8):1203-1212. doi: 10.1001/jamaoncol.2021.1590.

    PubMed 34081085

  • Kurman RJ, Shih IeM. The origin and pathogenesis of epithelial ovarian cancer: a proposed unifying theory. Am J Surg Pathol. 2010 Mar;34(3):433-43. doi: 10.1097/PAS.0b013e3181cf3d79.

    PubMed 20154587

  • Daly MB, Pal T, Berry MP, Buys SS, Dickson P, Domchek SM, Elkhanany A, Friedman S, Goggins M, Hutton ML; CGC; Karlan BY, Khan S, Klein C, Kohlmann W; CGC; Kurian AW, Laronga C, Litton JK, Mak JS; LCGC; Menendez CS, Merajver SD, Norquist BS, Offit K, Pederson HJ, Reiser G; CGC; Senter-Jamieson L; CGC; Shannon KM, Shatsky R, Visvanathan K, Weitzel JN, Wick MJ, Wisinski KB, Yurgelun MB, Darlow SD, Dwyer MA. Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 Jan 6;19(1):77-102. doi: 10.6004/jnccn.2021.0001.

    PubMed 33406487

  • Couch FJ, Shimelis H, Hu C, Hart SN, Polley EC, Na J, Hallberg E, Moore R, Thomas A, Lilyquist J, Feng B, McFarland R, Pesaran T, Huether R, LaDuca H, Chao EC, Goldgar DE, Dolinsky JS. Associations Between Cancer Predisposition Testing Panel Genes and Breast Cancer. JAMA Oncol. 2017 Sep 1;3(9):1190-1196. doi: 10.1001/jamaoncol.2017.0424.

    PubMed 28418444

  • Pal T, Permuth-Wey J, Betts JA, Krischer JP, Fiorica J, Arango H, LaPolla J, Hoffman M, Martino MA, Wakeley K, Wilbanks G, Nicosia S, Cantor A, Sutphen R. BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma cases. Cancer. 2005 Dec 15;104(12):2807-16. doi: 10.1002/cncr.21536.

    PubMed 16284991

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer and Breast Cancer, run by Peking University Third Hospital at 1 site in China.

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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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 China. 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?

Contact Associate Chief Physician/Associate Consultant, Doctor (18610689868, yuanli@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Ovarian Cancer (time frame: From the date of enrollment/surgery up to 15 years.). 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 NCT07532434, which also lists 12 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 15 Apr 2026.

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Clinical Trial NCT07532434 | AzTrials