Healthy Volunteers Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-50
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
has ovaries
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Self-Administered Sample Collection
Other interventionParticipants will collect vaginal swabs and a stool sample.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Healthy Volunteer1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov