Circulating cfDNA and HPV as Prognostic Biomarkers for First-Line Recurrent Metastatic Cervical Cancer

NCT07673211 | Not Yet Recruiting DMC

• 1 other identifier: IRB-2026-317（IIT）
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Cancer; Recurrent Cervical Cancer; Metastatic Cervical Cancer

Keywords

Cervical cancer; ctDNA; HPV cfDNA; Complete response; Prognosis

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  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.

Secondary Outcomes (2)

• Dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence

  Up to 3 years after enrollment

• Overall Survival (OS)

  Up to 3 years after enrollment

Study Arms (1)

Recurrent metastatic cervical cancer with complete response

Patients with recurrent and metastatic cervical cancer who achieved complete response after standard first-line systemic therapy.

Diagnostic Test: Biospecimen collection (peripheral blood and paraffin tumor tissue)

Interventions

Biospecimen collection (peripheral blood and paraffin tumor tissue) DIAGNOSTIC_TEST

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.

Recurrent metastatic cervical cancer with complete response

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent and metastatic cervical cancer who achieved complete response after first-line systematic treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Related Publications (10)

• 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.

  PMID: 38110977 BACKGROUND

• 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.

  PMID: 34210686 BACKGROUND

• 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.

  PMID: 34022731 BACKGROUND

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  PMID: 36634341 BACKGROUND

• 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.

  PMID: 34465660 BACKGROUND

• 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.

  PMID: 34031447 BACKGROUND

• 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.

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• 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.

  PMID: 36117009 BACKGROUND

• 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.

  PMID: 31076662 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue blocks of recurrent/metastatic cervical lesions archived in our pathology department are sectioned into 5-10 unstained slides (3-4 μm thick, \>25 mm² each) for HPV genotyping and gene variant testing. Serial 20 mL peripheral blood samples are collected in EDTA tubes at baseline (post complete response) and every 3 months for 1 year (5 time points total) to detect circulating tumor DNA.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share