Ovarian CancerNCT06962059
Healthy Volunteers Study
An observational study of Ovarian Cancer and Genetic Predisposition to Disease, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Genetic Predisposition to Disease
- What is being tested?
- Self-Administered Sample Collection
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 25 May 2027
- 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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- has ovaries
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Susan Domchek, MD, 855-216-0098, PennCancerTrials@emergingmed.com
Susan Domchek, MD
About this study
Official title: Vaginal Metabolome Healthy Volunteers Study
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.
Read the detailed description
This study will examine the role of the microbiome and its metabolites in early detection and prediction of ovarian cancer development. It has been previously shown that the composition and function of the microbiome may play a role in the development and progression of several types of cancer. One proposed mechanism by which the microbiome may contribute to cancer development is through the production of certain metabolic byproducts. Such metabolites produced or modified by the microbiome have emerged as a prominent factor with potential local and systemic effects on the host, and were proposed to mediate the microbiome's contribution to cancer development. Microbial metabolites can promote cancer development by activating signaling pathways that promote cell growth and survival. In addition, the microbiota affects carcinogenesis through the release of carcinogenic molecules, such as genotoxins, and through the production of tumor-promoting metabolites. Furthermore, microbial metabolites have been studied as potential biomarkers for cancer, with some research suggesting that certain microbial metabolites may be able to distinguish between healthy individuals and those with cancer. The microbiome of the female reproductive tract is relatively understudied compared to the gut microbiome, but recent studies have shown that it is present and diverse in various parts of the reproductive tract such as the vagina, cervix, and fallopian tubes. however, a microbiome or metabolome signature predictive of ovarian cancer has not yet been established. Eligible individuals will be consented to provide a one-time, self-administered vaginal swab sample and stool sample. Clinical research assistants/coordinators, genetic counselors, and/or study physicians will consent patients and process and store the samples of consented participants. Participants will be provided a stool collection kit at the time of consent with instructions for providing the sample and sending it back to the laboratory.
- Conditions
- Ovarian Cancer, Genetic Predisposition to Disease
- Being tested
- Self-Administered Sample Collection
- Keywords
- vaginal metabolome, ovarian cancer
- Medical subject headings
- Ovarian Neoplasms, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Administered Sample CollectionOther
Participants will collect vaginal swabs and a stool sample.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self-Administered Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome Involvement
Investigate the involvement of the microbiome and associated metabolites in ovarian cancer.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start21 Apr 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion25 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Domchek, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962059
- Sponsor's protocol ID
- UPCC 01025
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data of patients samples, survey answers, and complementary medical information will be shared with investigators at Stanford and Columbia. This information will be used to identify factors for analysis such as prescribed medications, treatment types and timeframes, among others.
Publications
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.
PubMed 35762531Manganaro 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.
PubMed 36093649Menon U, Karpinskyj C, Gentry-Maharaj A. Ovarian Cancer Prevention and Screening. Obstet Gynecol. 2018 May;131(5):909-927. doi: 10.1097/AOG.0000000000002580.
PubMed 29630008Cullin 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.
PubMed 34506740Levy 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.
PubMed 27474437Cao 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.
PubMed 36302024Kroemer 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.
PubMed 36658422Dmitrieva-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.
PubMed 35477756France 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.
PubMed 35246662Wang 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.
PubMed 34234149Kindschuh 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.
PubMed 36635575Asangba 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.
PubMed 36639731Zhou 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.
PubMed 30737418Cheng 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.
PubMed 32133297Nene 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.
PubMed 31300207
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Metabolome Healthy Volunteers Study
- ClinicalTrials.gov ID
- NCT06962059
- Acronym / sponsor ID
- UPCC 01025
- Conditions
- Ovarian Cancer, Genetic Predisposition to Disease
- Keywords
- vaginal metabolome, ovarian cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 25 May 2027 (estimated)
- First posted
- 8 May 2025 (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.
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.
Detailed description
This study will examine the role of the microbiome and its metabolites in early detection and prediction of ovarian cancer development. It has been previously shown that the composition and function of the microbiome may play a role in the development and progression of several types of cancer. One proposed mechanism by which the microbiome may contribute to cancer development is through the production of certain metabolic byproducts. Such metabolites produced or modified by the microbiome have emerged as a prominent factor with potential local and systemic effects on the host, and were proposed to mediate the microbiome's contribution to cancer development. Microbial metabolites can promote cancer development by activating signaling pathways that promote cell growth and survival. In addition, the microbiota affects carcinogenesis through the release of carcinogenic molecules, such as genotoxins, and through the production of tumor-promoting metabolites. Furthermore, microbial metabolites have been studied as potential biomarkers for cancer, with some research suggesting that certain microbial metabolites may be able to distinguish between healthy individuals and those with cancer. The microbiome of the female reproductive tract is relatively understudied compared to the gut microbiome, but recent studies have shown that it is present and diverse in various parts of the reproductive tract such as the vagina, cervix, and fallopian tubes. however, a microbiome or metabolome signature predictive of ovarian cancer has not yet been established. Eligible individuals will be consented to provide a one-time, self-administered vaginal swab sample and stool sample. Clinical research assistants/coordinators, genetic counselors, and/or study physicians will consent patients and process and store the samples of consented participants. Participants will be provided a stool collection kit at the time of consent with instructions for providing the sample and sending it back to the laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Other: Self-Administered Sample CollectionFemales 30 or older who do not have a genetic predisposition to ovarian cancer, are unaffected by cancer, and have not had bilateral oophorectomy. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- has ovaries
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Self-Administered Sample CollectionParticipants will collect vaginal swabs and a stool sample. | Other | Healthy Volunteer |
Primary outcome
Microbiome Involvement
Time frame: 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.
Investigate the involvement of the microbiome and associated metabolites in ovarian cancer.
Predictive Model
Time frame: 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.
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.
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 5 Feb 2026.
- Background: PubMed 35762531Manasa 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.
- Background: PubMed 36093649Manganaro 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.
- Background: PubMed 29630008Menon U, Karpinskyj C, Gentry-Maharaj A. Ovarian Cancer Prevention and Screening. Obstet Gynecol. 2018 May;131(5):909-927. doi: 10.1097/AOG.0000000000002580.
- Background: PubMed 34506740Cullin 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.
- Background: PubMed 27474437Levy 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.
- Background: PubMed 36302024Cao 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.
- Background: PubMed 36658422Kroemer 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.
- Background: PubMed 35477756Dmitrieva-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.
- Background: PubMed 35246662France 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.
- Background: PubMed 34234149Wang 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.
- Background: PubMed 36635575Kindschuh 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.
- Background: PubMed 36639731Asangba 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.
- Individual participant dataSharing planned: Yes. Deidentified data of patients samples, survey answers, and complementary medical information will be shared with investigators at Stanford and Columbia. This information will be used to identify factors for analysis such as prescribed medications, treatment types and timeframes, among others.
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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.
Susan Domchek, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Genetic Predisposition to Disease, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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 6 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 5 Feb 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 United States. 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 Catherine Wolfe, BA (215-360-0422, catherine.wolfe@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Involvement (time frame: 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.). The study lists 2 primary outcomes in all. 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 NCT06962059, which also lists 15 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 5 Feb 2026.