Clinical trial · Interventional
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
NCT04008563CI-TRIAL-00087224B-FiERCErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Hyperplasia | — | UNRESOLVED | — |
| Bariatric Surgery Candidate | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bariatric Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bariatric Surgery and Progestin Intrauterine Device
- description
- This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
- interventionNames
- Procedure: Bariatric Surgery
- type
- NO_INTERVENTION
- label
- Progestin Intrauterine Device Alone
- description
- This group will receive a progestin intrauterine device alone.
Primary outcomes (1)
- measure
- Recruitment Rate
- timeFrame
- Year 5
- description
- To determine the proportion of eligible women who agree to participate in the study (recruitment rate). The primary outcome will be met and a full scale randomized controlled trial to assess efficacy will be conducted if ≥ 40% recruitment rate is achieved. Patients' reasons for participation or non-participation will be recorded.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 41 Years
Show eligibility criteria text
Inclusion Criteria: * BMI ≥ 35 * Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia * Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by imaging performed (MRI, CT) * ECOG status \<2 * Desire for fertility preservation * No contraindications to progestin intrauterine device (IUD) * Have signed an approved informed consent form Exclusion Criteria: * Evidence of myometrial invasion or extra-uterine disease on imaging * High grade or p53 endometrial cancer * History of other malignancies, except if curatively treated with no evidence of disease for \> 5 years * Previous major upper abdominal surgery (ex. previous bariatric surgery, splenectomy, partial gastrectomy, liver resection, bowel resection). Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion. * Current use of weight loss medication. NB: patients taking glucagon-like peptide 1 (GLP-1) agonists (e.g., OZEMPIC) for the treatment of diabetes will not be excluded. * Contraindications to sleeve gastrectomy * Medical co-morbidity with end-organ dysfunction * Unable to understand and participate in the informed consent process * Currently pregnant * Active smoking in ≤6 months * Active substance use disorder * Current untreated or severe psychiatric issue
References
Publications (1)
- DERIVEDAgnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3. PMID 36971688