Investigations of Reproductive Cancers in Women

Launched by PINKDX, INC. · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on developing a new, non-invasive test to help identify uterine cancer in women aged 45 and older who experience abnormal bleeding, either before menopause or after. The goal is to provide a way to check for cancer without needing more invasive procedures. If you're a woman over 45 and have been having unusual bleeding, you might be eligible to participate in this study, especially if your doctor is trying to rule out cancer or other non-cancerous conditions like fibroids or cysts.

To join the study, you’ll need to be able to commit to regular visits and follow the study plan. It's important that you have a uterus and haven’t had a hysterectomy or a history of uterine cancer. During the study, you can expect to provide consent and participate in some scheduled procedures, all designed to make the testing process as easy and informative as possible. If you're interested, this could be a great opportunity to help advance how we detect gynecological cancers while also contributing to your own health assessment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.
• • 2. Willing and able to comply with scheduled visits, study plan, and other procedures.
• • 3. Expected to be available for the duration of the study and can be contacted by telephone during study participation.
• • 4. Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50).
• • 5. Presence of uterus.
• • 6. AUB or PMB being worked up to diagnose the cause of the bleeding
• Exclusion Criteria:
• • 1. 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.
• • 2. Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
• • 3. Women who have had a hysterectomy.
• • 4. Women with a known history of endometrial cancer or uterine sarcoma.
• • 5. Women who have received prior treatment for endometrial cancer.
• • 6. Inability or unwillingness to sign informed consent.
• • 7. Clinical suspicion of pregnancy.
• • 8. Women who have used a tampon within 7 days of sample collection.