Circulating cfDNA and HPV as Prognostic Biomarkers for First-Line Recurrent Metastatic Cervical Cancer
2026年6月23日 更新者:Tao Zhu、Zhejiang Cancer Hospital
A Prognostic Research on First-Line Recurrent and Metastatic Cervical Cancer Using Circulating Cell-Free DNA and Human Papillomavirus Detection
Primary Objective of this study: To investigate the correlation between longitudinal quantitative dynamics of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA) in peripheral blood and clinical prognosis among patients with recurrent and metastatic cervical cancer who achieved complete response following standard first-line systemic therapy.
研究概览
地位
尚未招聘
详细说明
This study plans to enroll patients with recurrent and metastatic cervical cancer who attain complete response after standard first-line systemic therapy.
A total of 20 mL peripheral blood will be collected from each subject every 3 months over a planned one-year period (5 sampling time points in total).
Plasma separated from blood samples will be subjected to quantitative detection and comparative analysis of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA).
Tumor tissue specimens (5-10 unstained paraffin sections) will also be collected from patients at the time of recurrent disease confirmation.
It is estimated that 60 patients will be recruited and followed up dynamically for 3 years to observe clinical prognosis.
This is a prospective, observational single-center cohort study.
Peripheral blood samples will only be collected at scheduled time points to explore novel biomarkers associated with disease recurrence.
研究类型
观察性的
注册 (估计的)
60
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients with recurrent and metastatic cervical cancer who achieved complete response after first-line systematic treatment.
描述
Inclusion Criteria:
- Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- Patients with first recurrent or metastatic cervical cancer (including primary stage IVB disease);
- Received standard first-line therapy (TP/TC regimen plus immunotherapy ± bevacizumab);
- Achieved complete response (CR) following standard first-line treatment;
- Archived pathological biopsy specimens of recurrent/metastatic lesions prior to treatment available in our hospital;
- Participated in clinical trials of pharmaceutical therapy for first-line recurrent/metastatic cervical cancer conducted at our institution;
- Voluntarily participates in this study and provides written informed consent;
- Agrees to serial peripheral blood collection at scheduled time points;
- Willing to complete scheduled follow-up visits;
- Aged ≥ 18 years old.
Exclusion Criteria:
- History of other malignant tumors within the past 2 years;
- Pregnant or breastfeeding women;
- Severe concomitant diseases, including: cardiovascular diseases (e.g., uncontrolled heart failure, unstable angina, etc.); pulmonary diseases (e.g., severe chronic obstructive pulmonary disease, interstitial pneumonia and other conditions impairing respiratory function); hepatic and renal dysfunction (e.g., decompensated liver cirrhosis, severe renal failure requiring dialysis, etc.);
- Refusal to sign informed consent;
- Refusal to undergo serial blood collection.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Recurrent metastatic cervical cancer with complete response
Patients with recurrent and metastatic cervical cancer who achieved complete response after standard first-line systemic therapy.
|
Longitudinal collection of peripheral blood plasma at scheduled time points and collection of archived paraffin-embedded recurrent tumor tissue sections for ctDNA and HPV cfDNA quantitative detection, HPV genotyping and gene variation analysis.
|
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 |
|---|---|---|
|
Disease-free survival (DFS)
大体时间:Up to 3 years after patient enrollment.
|
Time from enrollment to confirmation of disease recurrence or death from any cause, whichever occurs first, assessed over a 3-year follow-up period.
|
Up to 3 years after patient enrollment.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence
大体时间:Up to 3 years after enrollment
|
To evaluate the capacity of dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence in patients.
|
Up to 3 years after enrollment
|
|
Overall Survival (OS)
大体时间:Up to 3 years after enrollment
|
The proportion of patients surviving for 3 years from enrollment, defined as the time from study entry to death from any cause.
|
Up to 3 years after enrollment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Cabel L, Bonneau C, Bernard-Tessier A, Hequet D, Tran-Perennou C, Bataillon G, Rouzier R, Feron JG, Fourchotte V, Le Brun JF, Benoit C, Rodrigues M, Scher N, Minsat M, Legrier ME, Bieche I, Proudhon C, Sastre-Garau X, Bidard FC, Jeannot E. HPV ctDNA detection of high-risk HPV types during chemoradiotherapy for locally advanced cervical cancer. ESMO Open. 2021 Jun;6(3):100154. doi: 10.1016/j.esmoop.2021.100154. Epub 2021 May 19.
- Jeannot E, Latouche A, Bonneau C, Calmejane MA, Beaufort C, Ruigrok-Ritstier K, Bataillon G, Larbi Cherif L, Dupain C, Lecerf C, Popovic M, de la Rochefordiere A, Lecuru F, Fourchotte V, Jordanova ES, von der Leyen H, Tran-Perennou C, Legrier ME, Dureau S, Raizonville L, Bello Roufai D, Le Tourneau C, Bieche I, Rouzier R, Berns EMJJ, Kamal M, Scholl S. Circulating HPV DNA as a Marker for Early Detection of Relapse in Patients with Cervical Cancer. Clin Cancer Res. 2021 Nov 1;27(21):5869-5877. doi: 10.1158/1078-0432.CCR-21-0625. Epub 2021 Jul 1.
- Li L, Tong Y, Wu J, Xu X. Clinical applications and utility of ctDNA in cervical cancer and its precursor lesions: from screening to predictive biomarker. Cancer Cell Int. 2023 Dec 18;23(1):329. doi: 10.1186/s12935-023-03132-0.
- Ortega NM, Revilla-Leon M, Ortega R, Gomez-Polo C, Barmak AB, Gomez-Polo M. Comparison of surface roughness of additively manufactured implant-supported interim crowns fabricated with different print orientations. J Prosthodont. 2024 Feb;33(2):141-148. doi: 10.1111/jopr.13645. Epub 2023 Feb 6.
- Mathew JL. Cross-sectional Study to Identify the Range of Hemoglobin Levels in Normal Infants, Children, and Adolescents in India: Evidence-based Medicine Viewpoint. Indian Pediatr. 2021 Aug 15;58(8):786-787. No abstract available.
- Garcia J, Kamps-Hughes N, Geiguer F, Couraud S, Sarver B, Payen L, Ionescu-Zanetti C. Sensitivity, specificity, and accuracy of a liquid biopsy approach utilizing molecular amplification pools. Sci Rep. 2021 May 24;11(1):10761. doi: 10.1038/s41598-021-89592-8.
- de Oliveira J. The role of body image in lipedema. Maturitas. 2024 Apr;182:107884. doi: 10.1016/j.maturitas.2023.107884. Epub 2023 Nov 10. No abstract available.
- Zhou J, He X, Zhang Z, Wu G, Liu P, Wang D, Shi P, Zhang XX. Chemical-toxicological insights and process comparison for estrogenic activity mitigation in municipal wastewater treatment plants. Water Res. 2024 Apr 1;253:121304. doi: 10.1016/j.watres.2024.121304. Epub 2024 Feb 11.
- Hou JY, Chapman JS, Kalashnikova E, Pierson W, Smith-McCune K, Pineda G, Vattakalam RM, Ross A, Mills M, Suarez CJ, Davis T, Edwards R, Boisen M, Sawyer S, Wu HT, Dashner S, Aushev VN, George GV, Malhotra M, Zimmermann B, Sethi H, ElNaggar AC, Aleshin A, Ford JM. Circulating tumor DNA monitoring for early recurrence detection in epithelial ovarian cancer. Gynecol Oncol. 2022 Nov;167(2):334-341. doi: 10.1016/j.ygyno.2022.09.004. Epub 2022 Sep 16.
- Dagliyan O, Dokholyan NV, Hahn KM. Engineering proteins for allosteric control by light or ligands. Nat Protoc. 2019 Jun;14(6):1863-1883. doi: 10.1038/s41596-019-0165-3. Epub 2019 May 10.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2029年12月1日
研究注册日期
首次提交
2026年6月23日
首先提交符合 QC 标准的
2026年6月23日
首次发布 (实际的)
2026年6月29日
研究记录更新
最后更新发布 (实际的)
2026年6月29日
上次提交的符合 QC 标准的更新
2026年6月23日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB-2026-317(IIT)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
Individual participant data will not be shared with external researchers to protect patient privacy and comply with hospital data management regulations.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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