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NCT Number: NCT06527157

Investigations of Reproductive Cancers in Women

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.

Recruiting

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Key information

Age range

45 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama, Birmingham, Birmingham, Alabama, United States

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Presence of uterus.
  • AUB or PMB being worked up to diagnose the cause of the bleeding

Exclusion criteria

  • 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.
  • Women who have received prior treatment for endometrial cancer.
  • Inability or unwillingness to sign informed consent.
  • Clinical suspicion of pregnancy.
  • Women who have used a tampon within 7 days of sample collection.

Treatment and study plan

Primary outcomes

  1. Sensitivity

    Time frame: 12 months

    ability to detect cancer

Secondary outcomes

  1. Specificity

    Time frame: 12 months

    ability to identify benign cases

Study contacts

Contact information is provided by the study sponsor or research team.

VP, Clinical Operations

CONTACT

[email protected]

463-273-7024

Sponsors and collaborators

Lead sponsor

PinkDx, Inc.

Industry

Registry information

Official study title

PROspective ACcrual To Investigate reprOductive Cancers in womeN

Acronym: PROACTION:

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Jul 30, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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