Healthy Volunteers Study

NCT06962059 | Recruiting

• 1 other identifier: UPCC 01025
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the role of the bacterial environments and metabolites in the early detection and prediction of ovarian cancer development. Vaginal swabs and stool samples will be collected from healthy volunteers, or those without a known ovarian cancer diagnosis or genetic ovarian cancer risk. These samples will be compared to samples from participants with increased cancer risk and ovarian cancer diagnoses.

Conditions

Ovarian Cancer; Genetic Predisposition to Disease

Keywords

vaginal metabolome; ovarian cancer

Outcome Measures

Primary Outcomes (2)

• Microbiome Involvement

  Investigate the involvement of the microbiome and associated metabolites in ovarian cancer.

  One-time sample donation of vaginal swabs collected at the time of the patient's appointment. A subsequent stool sample will be provided within a week of the vaginal swab.

• Predictive Model

  Generate a predictive model for ovarian cancer risk and progression. Healthy volunteers will provide a control group to compare to BRCA-carrier and affected cohorts consented through the CREP Biobank study in order to mechanistically understand the function of the identified metabolites in disease prevention, initiation, progression, and treatment response.

  One-time sample donation of vaginal swabs collected at the time of the patient's appointment. A subsequent stool sample will be provided within a week of the vaginal swab.

Study Arms (1)

Healthy Volunteer

Females 30 or older who do not have a genetic predisposition to ovarian cancer, are unaffected by cancer, and have not had bilateral oophorectomy.

Other: Self-Administered Sample Collection

Interventions

Self-Administered Sample Collection OTHER

Participants will collect vaginal swabs and a stool sample.

Healthy Volunteer

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be patients of the Cancer Risk Evaluation Program at the Abramson Cancer Center. Patients who meet the above criteria will be approached to participate as healthy volunteers.

You may qualify if:

• has ovaries

You may not qualify if:

• genetic mutations which increase risk of ovarian cancer: BRCA1/2, BRIP1, PALB2, Lynch Syndrome (MLH1, MSH2/EPCAM, MSH6) and ATM
• no genetic testing results or unknown genetic status
• prior cancer diagnosis
• prior cancer treatment
• HRT use
• Antibiotic use (1 month prior to providing sample)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (15)

• Manasa G, Mascarenhas RJ, Shetti NP, Malode SJ, Aminabhavi TM. Biomarkers for Early Diagnosis of Ovarian Carcinoma. ACS Biomater Sci Eng. 2022 Jul 11;8(7):2726-2746. doi: 10.1021/acsbiomaterials.2c00390. Epub 2022 Jun 28.

  PMID: 35762531 BACKGROUND

• Manganaro L, Celli V, Viggiani V, Berardelli E, Granato T, Tartaglione S, Farina A, Catalano C, Angeloni A, Anastasi E. CT imaging phenotypes linked to CA125 and HE4 biomarkers are highly predictive in discriminating between hereditary and sporadic ovarian cancer patients. Tumour Biol. 2022;44(1):171-185. doi: 10.3233/TUB-211557.

  PMID: 36093649 BACKGROUND

• Menon U, Karpinskyj C, Gentry-Maharaj A. Ovarian Cancer Prevention and Screening. Obstet Gynecol. 2018 May;131(5):909-927. doi: 10.1097/AOG.0000000000002580.

  PMID: 29630008 BACKGROUND

• Cullin N, Azevedo Antunes C, Straussman R, Stein-Thoeringer CK, Elinav E. Microbiome and cancer. Cancer Cell. 2021 Oct 11;39(10):1317-1341. doi: 10.1016/j.ccell.2021.08.006. Epub 2021 Sep 9.

  PMID: 34506740 BACKGROUND

• Levy M, Thaiss CA, Elinav E. Metabolites: messengers between the microbiota and the immune system. Genes Dev. 2016 Jul 15;30(14):1589-97. doi: 10.1101/gad.284091.116.

  PMID: 27474437 BACKGROUND

• Cao Y, Oh J, Xue M, Huh WJ, Wang J, Gonzalez-Hernandez JA, Rice TA, Martin AL, Song D, Crawford JM, Herzon SB, Palm NW. Commensal microbiota from patients with inflammatory bowel disease produce genotoxic metabolites. Science. 2022 Oct 28;378(6618):eabm3233. doi: 10.1126/science.abm3233. Epub 2022 Oct 28.

  PMID: 36302024 BACKGROUND

• Kroemer G, McQuade JL, Merad M, Andre F, Zitvogel L. Bodywide ecological interventions on cancer. Nat Med. 2023 Jan;29(1):59-74. doi: 10.1038/s41591-022-02193-4. Epub 2023 Jan 19.

  PMID: 36658422 BACKGROUND

• Dmitrieva-Posocco O, Wong AC, Lundgren P, Golos AM, Descamps HC, Dohnalova L, Cramer Z, Tian Y, Yueh B, Eskiocak O, Egervari G, Lan Y, Liu J, Fan J, Kim J, Madhu B, Schneider KM, Khoziainova S, Andreeva N, Wang Q, Li N, Furth EE, Bailis W, Kelsen JR, Hamilton KE, Kaestner KH, Berger SL, Epstein JA, Jain R, Li M, Beyaz S, Lengner CJ, Katona BW, Grivennikov SI, Thaiss CA, Levy M. beta-Hydroxybutyrate suppresses colorectal cancer. Nature. 2022 May;605(7908):160-165. doi: 10.1038/s41586-022-04649-6. Epub 2022 Apr 27.

  PMID: 35477756 BACKGROUND

• France M, Alizadeh M, Brown S, Ma B, Ravel J. Towards a deeper understanding of the vaginal microbiota. Nat Microbiol. 2022 Mar;7(3):367-378. doi: 10.1038/s41564-022-01083-2. Epub 2022 Mar 4.

  PMID: 35246662 BACKGROUND

• Wang J, Li Z, Ma X, Du L, Jia Z, Cui X, Yu L, Yang J, Xiao L, Zhang B, Fan H, Zhao F. Translocation of vaginal microbiota is involved in impairment and protection of uterine health. Nat Commun. 2021 Jul 7;12(1):4191. doi: 10.1038/s41467-021-24516-8.

  PMID: 34234149 BACKGROUND

• Kindschuh WF, Baldini F, Liu MC, Liao J, Meydan Y, Lee HH, Heinken A, Thiele I, Thaiss CA, Levy M, Korem T. Preterm birth is associated with xenobiotics and predicted by the vaginal metabolome. Nat Microbiol. 2023 Feb;8(2):246-259. doi: 10.1038/s41564-022-01293-8. Epub 2023 Jan 12.

  PMID: 36635575 BACKGROUND

• Asangba AE, Chen J, Goergen KM, Larson MC, Oberg AL, Casarin J, Multinu F, Kaufmann SH, Mariani A, Chia N, Walther-Antonio MRS. Diagnostic and prognostic potential of the microbiome in ovarian cancer treatment response. Sci Rep. 2023 Jan 13;13(1):730. doi: 10.1038/s41598-023-27555-x.

  PMID: 36639731 BACKGROUND

• Zhou B, Sun C, Huang J, Xia M, Guo E, Li N, Lu H, Shan W, Wu Y, Li Y, Xu X, Weng D, Meng L, Hu J, Gao Q, Ma D, Chen G. The biodiversity Composition of Microbiome in Ovarian Carcinoma Patients. Sci Rep. 2019 Feb 8;9(1):1691. doi: 10.1038/s41598-018-38031-2.

  PMID: 30737418 BACKGROUND

• Cheng H, Wang Z, Cui L, Wen Y, Chen X, Gong F, Yi H. Opportunities and Challenges of the Human Microbiome in Ovarian Cancer. Front Oncol. 2020 Feb 18;10:163. doi: 10.3389/fonc.2020.00163. eCollection 2020.

  PMID: 32133297 BACKGROUND

• Nene NR, Reisel D, Leimbach A, Franchi D, Jones A, Evans I, Knapp S, Ryan A, Ghazali S, Timms JF, Paprotka T, Bjorge L, Zikan M, Cibula D, Colombo N, Widschwendter M. Association between the cervicovaginal microbiome, BRCA1 mutation status, and risk of ovarian cancer: a case-control study. Lancet Oncol. 2019 Aug;20(8):1171-1182. doi: 10.1016/S1470-2045(19)30340-7. Epub 2019 Jul 9.

  PMID: 31300207 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Genetic Predisposition to Disease

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; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Domchek, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Wolfe, BA

CONTACT

215-360-0422; catherine.wolfe@pennmedicine.upenn.edu

Jamie Brower, MS

CONTACT

215-662-7245; jabrower@pennmedicine.upenn.edu

Study Design

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

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 8, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): May 25, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be shared with investigators three months after enrollment is complete. This should provide time for enrolled subjects to complete participation, ensure all data entry is complete, and that all data from records is obtained.

Locations

US (1)