Investigations of Reproductive Cancers in Women
ConditionUterine Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age45-100
SponsorPinkDx, Inc.
About this trial
The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
Willing and able to comply with scheduled visits, study plan, and other procedures.
Expected to be available for the duration of the study and can be contacted by telephone during study participation.
Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50).
Disqualifiers
Investigator site staff members directly involved in the conduct of the study and their family members or subjects who are PinkDx, Inc. employees or their family members.
Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
Women who have had a hysterectomy.
Women with a known history of endometrial cancer or uterine sarcoma.
Trial population
Females 45 years and older seeking medical attention for abnormal uterine or postmenopausal bleeding.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
4,500 Participants
are grouped into 2 trial groupsGroup A: Benign
Group B: Malignant
Trial outcomes
Primary outcomes
1
Sensitivity
ability to detect cancer
Time frame
12 monthsSecondary outcomes
1
Specificity
ability to identify benign cases
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov