Clinical trial · Observational
Healthy Volunteers Study
Vaginal Metabolome Healthy Volunteers Study
NCT06962059CI-TRIAL-00102467recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genetic Predisposition to Disease | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-Administered Sample Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Healthy Volunteer
- description
- Females 30 or older who do not have a genetic predisposition to ovarian cancer, are unaffected by cancer, and have not had bilateral oophorectomy.
- interventionNames
- Other: Self-Administered Sample Collection
Primary outcomes (2)
- measure
- Microbiome Involvement
- timeFrame
- 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.
- description
- Investigate the involvement of the microbiome and associated metabolites in ovarian cancer.
- measure
- Predictive Model
- timeFrame
- 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.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * has ovaries Exclusion Criteria: * 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)
References
Publications (15)
- BACKGROUNDManasa 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
- BACKGROUNDManganaro 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
- BACKGROUNDMenon 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
- BACKGROUNDCullin 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
- BACKGROUNDLevy 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
- BACKGROUNDCao 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
- BACKGROUNDKroemer 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