子宮内膜がん患者における標準治療の決定を導くためのctDNA検査を用いた研究
標準治療を用いた進行性／再発性ミスマッチ修復欠損（MMR-D）／マイクロサテライト不安定性高（MSI-H）子宮体癌におけるctDNA情報に基づく免疫チェックポイント阻害剤減量の実用的パイロット研究
The researchers are doing this study to evaluate the use of circulating tumor DNA (ctDNA) testing in making treatment decisions for advanced/recurrent endometrial cancer that has a change (mutation) in the mismatch repair deficient (MMR-D) gene or microsatellite instability high (MSI-H) gene. The researchers will see how doctors and their patients use the results of ctDNA testing after 1 year of standard chemotherapy and immune checkpoint inhibitor (ICI) treatment to decide whether to continue maintenance ICI treatment past 1 year. The researchers will also look at the health outcomes of people in this study (for example, whether they are cancer free at the end of their participation in the study).
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ying Liu, MD, MPH
- 電話番号：646-888-4946
- メール：liuy6@mskcc.org
研究連絡先のバックアップ
- 名前：Paul Johannet, MD
- 電話番号：646-888-5327
研究場所
-
-
New Jersey
-
Basking Ridge、New Jersey、アメリカ、07920
- 募集
- Memorial Sloan Kettering Basking Ridge (All Protocol Activites)
-
コンタクト：
- Ying Liu, MD
- 電話番号：646-888-4946
-
Middletown、New Jersey、アメリカ、07748
- 募集
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
-
コンタクト：
- Ying Liu, MD
- 電話番号：646-888-4946
-
Montvale、New Jersey、アメリカ、07645
- 募集
- Memorial Sloan Kettering Bergen (All Protocol Activities)
-
コンタクト：
- Ying Liu, MD
- 電話番号：646-888-4946
-
-
New York
-
Commack、New York、アメリカ、11725
- 募集
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
-
コンタクト：
- Ying Liu, MD
- 電話番号：646-888-4946
-
Harrison、New York、アメリカ、10604
- 募集
- Memorial Sloan Kettering Westchester (All Protocol Activities)
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コンタクト：
- Ying Lui, MD
- 電話番号：646-888-4946
-
New York、New York、アメリカ、10065
- 募集
- Memorial Sloan Kettering Cancer Center
-
コンタクト：
- Roisin O'Cearbhaill, MD
- 電話番号：646-888-4227
-
コンタクト：
- Ying Liu, MD, MPH.
- 電話番号：646-888-4946
-
Rockville Centre、New York、アメリカ、11570
- 募集
- Memorial Sloan Kettering Nassau (All Protocol Activities)
-
コンタクト：
- Ying Liu, MD
- 電話番号：646-888-4946
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Patients must have pathologically confirmed endometrial cancer
-
Patients with advanced endometrial cancer
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Stage III with residual disease
°Select patients with Stage III disease and no residual disease can be enrolled after discussion with PI
-
Stage IV
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Recurrent endometrial cancer after adjuvant therapy only
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Patients can have primary or planned interval surgery
-
MMR-D on immunohistochemistry OR MSI-H using any commercially available test
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Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression.
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Eligible for standard of care chemotherapy with immune checkpoint inhibitor per treating investigator with no clinical contraindications
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For the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments, they need to be on treatment with no clinical evidence of disease progression.
-
Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy.
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Patients may have received prior hormonal therapy for treatment of endometrial cancer.
-
Patients may not have received prior therapy with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
- Except for the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments (chemotherapy and/or immune checkpoint inhibitors) per protocol.
-
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Age ≥ 18
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Not Pregnant and Not Nursing
研究計画
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：非ランダム化
- 介入モデル：並列代入
- 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：ctDNA-negative group
Participants in this group will have negative ctDNA test results at 1 year after they start standard treatment. (Negative results indicate that no cancer DNA is detected in their blood.) Participants in this group will decide with their doctor if they want to stop standard maintenance ICI treatment. |
Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test. at the 1-year timepoint Patients and providers will also complete surveys at various timepoints to evaluate distress, shared decision-making, acceptability and other factors contributing to the decision-making process. Will be performed within 6 months of receiving the 1-year clinical ctDNA result. Discussion via telephone or during a standard of care clinical visit (in person or telemedicine) with treating physician or team member within 28 days of clinical 1-year ctDNA result to discuss results with the patient and decide on de-escalation if applicable. |
|
実験的：ctDNA-positive group
Participants in this group will have positive ctDNA test results at 1 year after they start standard treatment. (Positive results indicate that cancer DNA is detected in their blood.) Participants in this group will continue receiving standard treatment with their doctor. |
Patients will undergo ctDNA sampling at the 1-year timepoint using the commercially available Natera SignateraTM test. at the 1-year timepoint Patients and providers will also complete surveys at various timepoints to evaluate distress, shared decision-making, acceptability and other factors contributing to the decision-making process. Will be performed within 6 months of receiving the 1-year clinical ctDNA result. Discussion via telephone or during a standard of care clinical visit (in person or telemedicine) with treating physician or team member within 28 days of clinical 1-year ctDNA result to discuss results with the patient and decide on de-escalation if applicable. |
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 |
|---|---|---|
|
will test the feasibility of ct-DNA
時間枠：1 year
|
informed de-escalation of standard of care ICI maintenance therapy defined as willingness of patients/providers to stop ICI therapy after 1 year in those with negative ctDNA testing. |
1 year
|
協力者と研究者
捜査官
- 主任研究者：Ying Liu, MD, MPH、Memorial Sloan Kettering Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-337
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?
IPD プランの説明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。