Clinical trial · Observational

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

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

NCT07673211CI-TRIAL-00116160not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cervical Cancer	Malignant Cervical Neoplasm	CURATED_EXACT	0.92
Metastatic Cervical Cancer	Malignant Cervical Neoplasm	CURATED_BROADER	0.78
Recurrent Cervical Cancer	Malignant Cervical Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Biospecimen collection (peripheral blood and paraffin tumor tissue)	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

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

Primary outcomes (1)

measure
Disease-free survival (DFS)
timeFrame
Up to 3 years after patient enrollment.
description
Time from enrollment to confirmation of disease recurrence or death from any cause, whichever occurs first, assessed over a 3-year follow-up period.

Secondary outcomes (2)

measure
Dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence
timeFrame
Up to 3 years after enrollment

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
2. Patients with first recurrent or metastatic cervical cancer (including primary stage IVB disease);
3. Received standard first-line therapy (TP/TC regimen plus immunotherapy ± bevacizumab);
4. Achieved complete response (CR) following standard first-line treatment;
5. Archived pathological biopsy specimens of recurrent/metastatic lesions prior to treatment available in our hospital;
6. Participated in clinical trials of pharmaceutical therapy for first-line recurrent/metastatic cervical cancer conducted at our institution;
7. Voluntarily participates in this study and provides written informed consent;
8. Agrees to serial peripheral blood collection at scheduled time points;
9. Willing to complete scheduled follow-up visits;
10. Aged ≥ 18 years old.

Exclusion Criteria:

1. History of other malignant tumors within the past 2 years;
2. Pregnant or breastfeeding women;
3. 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.);
4. Refusal to sign informed consent;
5. Refusal to undergo serial blood collection.

References

Publications (10)

BACKGROUNDLi 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
BACKGROUNDJeannot 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
BACKGROUNDCabel 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
BACKGROUNDOrtega 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. PMID 36634341
BACKGROUNDMathew 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
BACKGROUNDGarcia 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.