Overexpression of 17β-hydroxysteroid dehydrogenase type 1 increases the exposure of endometrial cancer to 17β-estradiol.
Karlijn M C Cornel, Roy F P M Kruitwagen, Bert Delvoux...
https://pubmed.ncbi.nlm.nih.gov/22362820/Actively Recruiting
Led by Radboud University Medical Center · Updated on 2023-01-18
150
Participants Needed
1
Research Sites
45 weeks
Total Duration
The PROMOTE study focuses on women with advanced stage FIGO stage III and IV or recurrent endometrial cancer. Researchers aim to improve how hormonal therapy is used by analyzing tumor tissue taken before treatment to better predict which patients may respond. This is important because hormonal therapy is less aggressive and better tolerated than chemotherapy, but current use relies heavily on physician experience rather than detailed molecular criteria. Participants are women planned to receive hormonal therapy for their advanced or recurrent endometrial cancer. The study observes these patients as they undergo hormonal treatment without altering their care. Tumor biopsies taken within 120 days before starting therapy are analyzed to correlate molecular features with treatment response. The study does not involve additional experimental treatments but collects clinical and molecular data during usual care. During the study, participants responses to hormonal therapy are tracked over two years, measuring response rate, progression-free survival, and clinical benefit. Quality of life is also assessed over six months. Researchers collect information from biopsies and monitor health outcomes without adding extra interventions. The study runs from October 2022 until September 2027, allowing long-term follow-up of participants treatment outcomes and quality of life.
CONDITIONS
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer
M
Maartje Luijten, MD
H
Hanny Pijnenborg, MD PhD
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Radboud University Medical Center
Lead Sponsor
Haukeland University Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive hormonal therapy for advanced or recurrent endometrial cancer.
Regular visits during treatment period
Duration - Up to 2 years
Participants are monitored to evaluate treatment response and quality of life after hormonal therapy.
Visits up to 2 years after starting treatment, including assessments at 6 months and 2 years
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Lead Sponsor
Haukeland University Hospital
Collaborating Sponsor