A Pilot Study Investigating the Effect of Chemotherapy on the Tumoral Immunoprofile of Gynecologic Cancers
研究概览
详细说明
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).
研究类型
注册 (实际的)
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27710
- Duke Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in number and type of tumor infiltrating lymphocytes
大体时间：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
大体时间：baseline, post treatment (approximately 6 months)
|
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.
|
baseline, post treatment (approximately 6 months)
|
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Change in tumor expression level of PD-L1
大体时间：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
大体时间：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)
|
合作者和调查者
调查人员
- 首席研究员：Angeles A Secord, MD、Duke Cancer Institute
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.