A Pilot Study Investigating the Effect of Chemotherapy on the Tumoral Immunoprofile of Gynecologic Cancers
調査の概要
詳細な説明
This is a single-institution, non-interventional prospective observational study allowing for specimen and data collection. All participants will receive standard of care surgery and chemotherapy, determined by the gynecologic oncologist and per institutional protocols. Patients with a presumed diagnosis of an eligible gynecologic malignancy (epithelial ovarian, fallopian tube, primary peritoneal, or uterine endometrial cancer) who are being considered for neoadjuvant chemotherapy prior to confirmatory biopsy will be given the option to enroll on this study.
Patients will undergo standard biopsy or endometrial curettage to confirm diagnosis. Additional tumor tissue for research purposes will be collected at the time of biopsy (if safely available). Patients who are undergoing diagnostic or therapeutic paracentesis will have the option to consent to allow excess ascites to be evaluated in this research protocol. Additionally, a research blood sample will be collected on the same day as the biopsy/curettage.
After confirmation of diagnosis, chemotherapy administration will proceed per standard institutional protocol and surgical planning will be performed by the treating gynecologic oncologist. Excess tumor tissue and ascites from the cytoreductive surgery will be collected for immune profiling. An additional vial of blood for research will be collected within 3 days prior to surgery. Post-surgical treatment and chemotherapy will proceed per standard procedures. After completion of post-surgical adjuvant therapy, an additional vial of blood for research will be collected (at next scheduled clinic visit).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke Cancer Institute
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Presumed diagnosis of tumor of müllerian origin, specifically epithelial ovarian, fallopian tube, primary peritoneal, or uterine endometrial cancer. After biopsy portion of study, only patients with histologically or cytologically confirmed diagnosis of eligible malignancies will continue.
- Be considered a candidate for neoadjuvant chemotherapy per institutional standards.
- Be willing and able to provide written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen upon agreement of the investigator.
- Have a performance status of 0-2 on the ECOG Performance Scale.
- Female subjects of childbearing potential should have a negative urine pregnancy test within 48 hours prior initial biopsy or administration of chemotherapy whichever comes first.
Exclusion Criteria:
- Is currently participating and receiving a study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device for this diagnosis.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
- Has a history or current evidence of any condition (i.e. infection), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding.
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
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 |
|---|---|---|
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Change in number and type of tumor infiltrating lymphocytes
時間枠：baseline, post treatment (approximately 6 months)
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To assess changes in the immune response through the characterization of tumor infiltrating lymphocytes (TILs) after administration of chemotherapy.
Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.
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baseline, post treatment (approximately 6 months)
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Change in expression level of Inflammatory mediators
時間枠：baseline, post treatment (approximately 6 months)
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To assess changes in immune response through the characterization of inflammatory mediators after administration of chemotherapy.
Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.
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baseline, post treatment (approximately 6 months)
|
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Change in tumor expression level of PD-L1
時間枠：baseline, post treatment (approximately 6 months)
|
To assess changes in the immune response through the characterization of tumor expression of PD-L1 after administration of chemotherapy.
Identify immune signatures/biomarkers that predict treatment outcomes.
Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.
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baseline, post treatment (approximately 6 months)
|
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Changes in HLA-type
時間枠：baseline, post treatment (approximately 6 months)
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To assess changes in HLA-type after administration of chemotherapy.
Identify immune signatures/biomarkers that predict treatment outcomes.
Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.
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baseline, post treatment (approximately 6 months)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Angeles A Secord, MD、Duke Cancer Institute
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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。
卵巣がんの臨床試験
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