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

An observational study of Cervical Cancer and Recurrent Cervical Cancer, run by Zhejiang Cancer Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cervical Cancer, Recurrent Cervical Cancer, Metastatic Cervical Cancer
What is being tested?: Biospecimen collection (peripheral blood and paraffin tumor tissue)
How many people: 60 participants
Where: No sites listed yet
Study dates: Jun 2026to Dec 2029
How long will I take part?: 3 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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;

Show all 10Show fewer

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.

Who cannot join

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.

About this study

Official title: A Prognostic Research on First-Line Recurrent and Metastatic Cervical Cancer Using Circulating Cell-Free DNA and Human Papillomavirus Detection

Read the detailed description

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.

Conditions: Cervical Cancer, Recurrent Cervical Cancer, Metastatic Cervical Cancer
Being tested: Biospecimen collection (peripheral blood and paraffin tumor tissue)
Keywords: Cervical cancer, ctDNA, HPV cfDNA, Complete response, Prognosis
Medical subject headings: Uterine Cervical Neoplasms, Pathologic Complete Response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT07673211
Study group	Role	What they receive
Recurrent metastatic cervical cancer with complete response		Patients with recurrent and metastatic cervical cancer who achieved complete response after standard first-line systemic therapy. Receives: Diagnostic Test: Biospecimen collection (peripheral blood and paraffin tumor tissue)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
To evaluate the capacity of dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence in patients.
Measured: Up to 3 years after enrollment
Overall Survival (OS)
The proportion of patients surviving for 3 years from enrollment, defined as the time from study entry to death from any cause.
Measured: Up to 3 years after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2026Dec 2029

First posted29 Jun 2026
Study startJun 2026 (estimated)
Primary completionDec 2028 (estimated)
Study completionDec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 60 participants (estimated)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT07673211
Sponsor's protocol ID: IRB-2026-317（IIT）
Status last verified: Jun 2026
First submitted: 23 Jun 2026
Last updated: 29 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared with external researchers to protect patient privacy and comply with hospital data management regulations.

Publications

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.
PubMed 38110977
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.
PubMed 34210686
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.
PubMed 34022731
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.
PubMed 36634341
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.
PubMed 34465660
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.
PubMed 34031447
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.
PubMed 37989642
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.
PubMed 38364463
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.
PubMed 36117009
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.
PubMed 31076662

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

All Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prognostic Research on First-Line Recurrent and Metastatic Cervical Cancer Using Circulating Cell-Free DNA and Human Papillomavirus Detection
ClinicalTrials.gov ID: NCT07673211
Acronym / sponsor ID: IRB-2026-317（IIT）
Conditions: Cervical Cancer, Recurrent Cervical Cancer, Metastatic Cervical Cancer
Keywords: Cervical cancer, ctDNA, HPV cfDNA, Complete response, Prognosis
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Zhejiang Cancer HospitalUniversity, hospital or other
Study start: Jun 2026 (estimated)
Primary completion: Dec 2028 (estimated)
Study completion: Dec 2029 (estimated)
First posted: 29 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 1

Arm	Type	Receives
Recurrent metastatic cervical cancer with complete response	–	Diagnostic Test: Biospecimen collection (peripheral blood and paraffin tumor tissue)Patients with recurrent and metastatic cervical cancer who achieved complete response after standard first-line systemic therapy.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with recurrent and metastatic cervical cancer who achieved complete response after first-line systematic treatment.

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biospecimen collection (peripheral blood and paraffin tumor tissue)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.	Diagnostic test	Recurrent metastatic cervical cancer with complete response

Primary outcome

Disease-free survival (DFS)
Time frame: 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.

2 secondary outcomes

Dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence
Time frame: Up to 3 years after enrollment
Overall Survival (OS)
Time frame: Up to 3 years after enrollment

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
Background: PubMed 38110977Li 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.
Background: PubMed 34210686Jeannot 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.
Background: PubMed 34022731Cabel 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.
Background: PubMed 36634341Ortega 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.
Background: PubMed 34465660Mathew 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.
Background: PubMed 34031447Garcia 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.
Background: PubMed 37989642de 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.
Background: PubMed 38364463Zhou 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.
Background: PubMed 36117009Hou 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.
Background: PubMed 31076662Dagliyan 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.
Individual participant dataSharing planned: No. Individual participant data will not be shared with external researchers to protect patient privacy and comply with hospital data management regulations.

Related trials for Cervical Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
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RecruitingPhase 2
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RecruitingPhase 4
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Head and Neck Cancer (H&N)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer and Recurrent Cervical Cancer, run by Zhejiang Cancer Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) (time frame: Up to 3 years after patient enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07673211, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.