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Healthy Volunteers Study

NCT06962059RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

Start Date

2025-04-21

Completion Date

2027-01-15

Study Type

OBSERVATIONAL

Official Title

Vaginal Metabolome Healthy Volunteers Study

Interventions

Self-Administered Sample Collection

Conditions

Ovarian CancerGenetic Predisposition to Disease

Eligibility

Age Range

30 Years – 50 Years

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

Microbiome Involvement

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

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.

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.

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.

Locations

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, United States

Linked Papers

2023-01-13

Diagnostic and prognostic potential of the microbiome in ovarian cancer treatment response

AbstractOvarian cancer (OC) is the second most common gynecological malignancy and the fifth leading cause of death due to cancer in women in the United States mainly due to the late-stage diagnosis of this cancer. It is, therefore, critical to identify potential indicators to aid in early detection and diagnosis of this disease. We investigated the microbiome associated with OC and its potential role in detection, progression as well as prognosis of the disease. We identified a distinct OC microbiome with general enrichment of several microbial taxa, including Dialister, Corynebacterium, Prevotella, and Peptoniphilus in the OC cohort in all body sites excluding stool and omentum which were not sampled from the benign cohort. These taxa were, however, depleted in the advanced-stage and high-grade OC patients compared to early-stage and low-grade OC patients suggestive of decrease accumulation in advanced disease and could serve as potential indicators for early detection of OC. Similarly, we also observed the accumulation of these mainly pathogenic taxa in OC patients with adverse treatment outcomes compared to those without events and could also serve as potential indicators for predicting patients’ responses to treatment. These findings provide important insights into the potential use of the microbiome as indicators in (1) early detection of and screening for OC and (2) predicting patients’ response to treatment. Given the limited number of patients enrolled in the study, these results would need to be further investigated and confirmed in a larger study.

2022-06-28

Biomarkers for Early Diagnosis of Ovarian Carcinoma

The leading cause of gynecological cancer-related morbidity and mortality is ovarian cancer (OC), which is dubbed a silent killer. Currently, OC is a target of intense biomarker research, because it is often not discovered until the disease is advanced. The goal of OC research is to develop effective tests using biomarkers that can detect the disease at the earliest stages, which would eventually decrease the mortality, thereby preventing recurrence. Therefore, there is a pressing need to revisit the existing biomarkers to recognize the potential biomarkers that can lead to efficient predictors for the OC diagnosis. This Perspective covers an update on the currently available biomarkers used in the triaging of OC to gain certain insights into the potential role of these biomarkers and their estimation that are crucial to the understanding of neoplasm progression, diagnostics, and therapy.

CT imaging phenotypes linked to CA125 and HE4 biomarkers are highly predictive in discriminating between hereditary and sporadic ovarian cancer patients

BACKGROUND: Hereditary ovarian cancers (HOC) represent about 23% of ovarian cancer (OC) cases: they are most frequently related to germline mutations in the BRCA genes. OBJECTIVE: We aimed to compare CA125/HE4 serum levels and Computed Tomography (CT) features at time of ovarian cancer (OC) diagnosis in two populations: BRCA mutant and BRCA wild-type (WT) OC, and to investigate the relationship between this laboratory and radiological biomarker and BRCA mutation status. METHODS: This retrospective study included 60 newly diagnosed OC patients with FIGO stage IIIC-IV disease, tested for BRCA1/2 germline mutation status of which preoperative CT scan and serum tumor marker assay were available. RESULTS: The median level of CA125 (708 U/mL) was significantly higher ( p < 0.002) in BRCA1/2 mutated patients than in WT patients (176 U/mL), whereas the median level of HE4 (492 pmol/L) was significantly higher ( p < 0.002) in WT than in BRCA-mutated patients (252 pmol/L). BRCA mutation carriers showed a higher incidence of bilateral ovarian masses ( p = 0.0303) characterized by solid structures ( p < 0.00001), higher peritoneal tumor load, macronodular implants >2 cm ( p = 0.000099), increased frequency of lymphadenopathies ( p = 0.019), and metastasis ( p = 0.052) compared to patients with BRCA WT. CONCLUSIONS: Tumor markers and CT patterns may help in identifying BRCA mutation status in OC directing patients towards a personalized treatment.

Linked Investigators

G. Manasa

Nagaraj P. Shetti

Ronald J. Mascarenhas

Shweta J. Malode