Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer (SWIFT)
2026年9月9日 更新者：Aparna A. Kamat、The Methodist Hospital Research Institute
SEMAGLUTIDE, WEIGHT LOSS, AND INTRAUTERINE THERAPY FOR FERTILITY-SPARING AND CONSERVATIVE TREATMENT FOR ENDOMETRIAL ATYPICAL HYPERPLASIA AND EARLY-STAGE, GRADE 1 ENDOMETRIOID ENDOMETRIAL CANCER
The goal of this clinical trial is to learn if a combination treatment of a hormonal intrauterine device (LNG-IUD), semaglutide, and a structured weight loss program can treat endometrial atypical hyperplasia or grade 1 endometrioid endometrial cancer while preserving fertility in women of reproductive age with endometrial atypical hyperplasia (EAH) or FIGO grade 1 endometrioid endometrial cancer who wish to preserve their fertility. The main questions it aims to answer are:
- What proportion of participants achieve a complete pathological response after treatment?
- How durable is the response at 12 months?
- What effect does the treatment have on metabolic outcomes (weight, BMI, HbA1c) and quality of life?
Participants will:
- Receive an LNG-IUD
- Receive semaglutide 2.4mg
- Participate in a structured weight loss program
- Undergo hysteroscopy with endometrial sampling to assess treatment response
- Complete quality-of-life assessments at baseline, 6 months, and 12 months
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
48
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Texas
-
Houston、Texas、アメリカ、77030
- Houston Methodist at The Medical Center
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コンタクト：
- Jaya S. Kamath, MS
- 電話番号：713-441-6616
- メール：jskamath@houstonmethodist.org
-
Houston、Texas、アメリカ、77030
- Houston Methodist Sugar Land
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コンタクト：
- Jaya S. Kamath, MS
- 電話番号：713-441-6616
- メール：jskamath@houstonmethodist.org
-
Houston、Texas、アメリカ、77030
- Houston Methodist Willowbrook
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コンタクト：
- Jaya S. Kamath, MS
- 電話番号：713-441-6616
- メール：jskamath@houstonmethodist.org
-
Houston、Texas、アメリカ、77030
- Houston Methodist Woodlands
-
コンタクト：
- Jaya S. Kamath, MS
- 電話番号：713-441-6616
- メール：jskamath@houstonmethodist.org
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Histological Diagnosis: Histologically confirmed endometrial atypical hyperplasia or FIGO grade 1 endometrioid Endometrial Cancer
Imaging eligibility (for patients with endometrial cancer):
- Depth of myometrial invasion <50% confirmed by MRI or disease limited to the endometrium
- No evidence of extrauterine or metastatic disease on imaging.
Treatment Rationale (at least one of the following must apply):
- Desire for future fertility: Patient expresses a documented desire to preserve the uterus and future reproductive function, with explicit acknowledgment that fertility-sparing treatment is not standard of care for endometrial cancer.
- Medical inoperability: patients are considered a poor surgical candidate due to:
i. Class III obesity (BMI ≥40 kg/m²); or ii. ASA Physical Status Classification score ≥3.
- Metabolic Profile: BMI ≥ 30 kg/m², or BMI 27-29.9 kg/m² with at least one weight-related comorbidity (hypertension, type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease).
Progestin washout: patients with prior progestin exposure are eligible provided the following minimum washout periods have been observed.
- Oral progestins: 7 days
- Injectable, short acting: 14 days
- Injectable, long acting: 6 months
- Contraceptive implant: 28 days
- LNG-IUD: 7 days after removal
Exclusion Criteria:
- Age ≥18 years
- Negative pregnancy test at screening
- Ability to provide written informed consent and comply with study procedures
- Willingness to undergo genetic counseling and MMR/IHC tumor profiling
- Willingness and ability to participate in a structured weight loss program, including attendance at counseling sessions (in person or virtual) and adherence to dietary and physical activity goals.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Combination Fertility-Sparing Treatment
Participants will receive a three-component combination intervention consisting of: (1) a levonorgestrel-releasing intrauterine device (LNG-IUD), inserted at baseline; (2) semaglutide 2.4 mg, administered per standard dosing schedule; and (3) a structured weight loss program.
Participants will undergo hysteroscopy with endometrial sampling to assess pathological response.
Treatment will be administered for 6 months of active intervention, followed by a 6-month follow-up period.
|
Semaglutide 2.4 mg administered subcutaneously once weekly, following standard dose-escalation protocol, for the duration of the 6-month active treatment period.
Used off-label in this trial for its metabolic effects in combination with LNG-IUD, rather than as monotherapy for weight loss.
Levonorgestrel-releasing intrauterine device inserted at study baseline and maintained through the active treatment and follow-up periods, providing continuous local progestin delivery to the endometrium in combination with systemic semaglutide.
A structured, protocol-defined weight loss program combining dietary counseling and physical activity guidance, delivered concurrently with pharmacologic and device-based treatment to support metabolic response, distinct from weight loss achieved through semaglutide alone.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pathological Response Rate
時間枠：6 months
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Pathological Response Rate (PRR) defined as the rate of regression of atypical hyperplasia or carcinoma on histopathological examination of the 6-month (end-of-treatment) hysteroscopic sample
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6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to response
時間枠：12 months
|
Time to response in months from treatment initiation to first documented histopathological regression
|
12 months
|
|
Adverse events
時間枠：12 months
|
Incidence and severity of adverse events, graded per NCI-CTCAE v5.0, including drug-related (semaglutide) and device-related (LNG-IUD) events
|
12 months
|
|
Durable response rate
時間枠：12 months
|
The proportion of participants who achieve a complete pathological response and maintain that response, without evidence of disease recurrence or progression, through 12 months following treatment initiation.
Durable response will be assessed via hysteroscopy with endometrial sampling.
|
12 months
|
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Disease progression rate
時間枠：12 months
|
The proportion of participants who experience disease progression, defined as an increase in histologic grade or stage of endometrial atypical hyperplasia or endometrial cancer, without ever achieving a complete pathological response, assessed through 12 months from treatment initiation.
Disease status will be assessed via hysteroscopy with endometrial sampling.
|
12 months
|
|
Recurrence rate
時間枠：12 months
|
The proportion of participants who experience recurrence of endometrial atypical hyperplasia or endometrial cancer following an initial complete pathological response, assessed through 12 months from treatment initiation.
Disease status will be assessed via hysteroscopy with endometrial sampling.
|
12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body weight change
時間枠：12 months
|
Change in body weight, measured in kilograms, from baseline to 6 and 12 months following treatment initiation.
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12 months
|
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Body mass index (BMI) change
時間枠：12 months
|
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared, from baseline to 6 and 12 months following treatment initiation.
|
12 months
|
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Waist circumference change
時間枠：12 months
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Change in waist circumference, measured in centimeters, from baseline to 6 and 12 months following treatment initiation.
|
12 months
|
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Hip circumference change
時間枠：12 months
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Change in hip circumference, measured in centimeters, from baseline to 6 and 12 months following treatment initiation.
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12 months
|
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Waist-to-hip ratio change
時間枠：12 months
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Change in waist-to-hip ratio, calculated as waist circumference divided by hip circumference, from baseline to 6 and 12 months following treatment initiation.
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12 months
|
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Glycated Hemoglobin change
時間枠：12 months
|
Change in glycated hemoglobin (HbA1c), measured as a percentage, from baseline to 6 and 12 months following treatment initiation.
|
12 months
|
|
Weight-Related Quality of Life (WRQOL)
時間枠：12 months
|
Change in weight-related quality of life, assessed using a validated WRQOL questionnaire, from baseline to 6 and 12 months following treatment initiation.
|
12 months
|
|
Health-Related Quality of Life (HRQOL)
時間枠：12 months
|
Change in health-related quality of life, assessed using a validated HRQOL questionnaire, from baseline to 6 and 12 months following treatment initiation.
|
12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Aparna A. Kamat, MD、The Methodist Hospital Research Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Wang L, Xu R, Kaelber DC, Berger NA. Glucagon-Like Peptide 1 Receptor Agonists and 13 Obesity-Associated Cancers in Patients With Type 2 Diabetes. JAMA Netw Open. 2024 Jul 1;7(7):e2421305. doi: 10.1001/jamanetworkopen.2024.21305.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2031年12月31日
試験登録日
最初に提出
2026年9月9日
QC基準を満たした最初の提出物
2026年9月9日
最初の投稿 (実際)
2026年9月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月9日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PRO00043004
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant data, including the study protocol and statistical analysis plan, will be made available to researchers who provide a methodologically sound proposal, beginning 12 months after publication of the primary results and ending 36 months after publication.
Data will be shared for the purpose of achieving the aims outlined in the approved proposal, following execution of a data access agreement.
IPD 共有時間枠
Data will become available beginning 12 months after publication of the primary study results and will remain available for 36 months thereafter.
IPD 共有アクセス基準
De-identified individual participant data, including the study protocol, statistical analysis plan, and informed consent form, will be available to researchers who provide a scientifically sound proposal for data use.
Requests should be directed to the principal investigator.
Proposals will be reviewed to confirm that the intended use is consistent with the original trial objectives and applicable data protection regulations.
Approved requesters will be required to sign a data access agreement prior to receiving data.
Access will be granted for the purpose of achieving the aims outlined in the approved proposal.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
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