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Tests treatment safety and results for Endometrioid Endometrial Adenocarcinoma
Official title A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
ClinicalTrials.gov ID: NCT07107334
What this study is testing
What is Glucagon-like peptide 1 receptor agonist?
Glucagon-like peptide 1 receptor agonist is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for endometrioid endometrial adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing. GLP-1RA are a class of medications that mimic the natural hormone glucagon-like peptide-1.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Adults ≥ 18 years old
- A pathological diagnosis with in the past 4 months consistent with grade 1 endometrioid endometrial adenocarcinoma or EIN
- For people with a diagnosis of endometrial intraepithelial neoplasia/grade 1 endometrioid endometrial adenocarcinoma prior to enrollment in the...
- ECOG Performance Status of 0 to 3
- For those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound
You likely can't join if
- people with grade 2 or 3 endometroid or any non-endometrioid histology (i.e., clear cell, carcinoma, serous)
- Clinical suspicion of metastatic disease as assessed by the treating physician or confirmed metastatic disease based on imaging
- people with abnormal cervical cytology
- people who are diagnosed with thyroid cancer, pancreatitis, or multiple endocrine neoplasia syndrome type 2
- people who are confirmed to be pregnant or breastfeeding
- History of medullary thyroid cancer
See the full eligibility criteria
- Adults ≥ 18 years old
- A pathological diagnosis with in the past 4 months consistent with grade 1 endometrioid endometrial adenocarcinoma or EIN
- For people with a diagnosis of endometrial intraepithelial neoplasia/grade 1 endometrioid endometrial adenocarcinoma prior to enrollment in the study, and with a diagnosis made outside this institution, the diagnostic...
- ECOG Performance Status of 0 to 3
- For those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound
- BMI ≥ 30 kg/m2 and one of the following (per medical record or self-report):
- Multiple medical co-morbidities (defined as American Society of Anesthesiologists [ASA] score ≥ 3) at physician discretion
- Fertility desire
- Subject has had appropriate age-related breast examinations and imagining prior to study enrollment, as documented in the medical record or via investigator confirmation.
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
- people with grade 2 or 3 endometroid or any non-endometrioid histology (i.e., clear cell, carcinoma, serous)
- Clinical suspicion of metastatic disease as assessed by the treating physician or confirmed metastatic disease based on imaging
- people with abnormal cervical cytology
- people who are diagnosed with thyroid cancer, pancreatitis, or multiple endocrine neoplasia syndrome type 2
- people who are confirmed to be pregnant or breastfeeding
- History of medullary thyroid cancer
- people with known current or history of hormonally- sensitive carcinoma (e.g., breast, melanoma)
- people actively taking GLP-1RA for more than 14 days at time of consent.
- people with levonorgestrel-releasing intrauterine system placed \>45 days prior to study enrollment.
- people must not have more than one active malignancy at the time of enrollment (people with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with safety or how...
- History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or...
- Prisoners or people who are involuntarily incarcerated, or people who are compulsorily detained for treatment of either a psychiatric or physical illness.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.