- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07673211
Circulating cfDNA and HPV as Prognostic Biomarkers for First-Line Recurrent Metastatic Cervical Cancer
23. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
60
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with recurrent and metastatic cervical cancer who achieved complete response after first-line systematic treatment.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease-free survival (DFS)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. december 2028
Studieafslutning (Anslået)
1. december 2029
Datoer for studieregistrering
Først indsendt
23. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juni 2026
Først opslået (Faktiske)
29. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Patologiske processer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Sygdomsegenskaber
- Livmodersygdomme
- Kønssygdomme, kvindelige
- Genitale neoplasmer, kvindelige
- Livmoderhalssygdomme
- Uterine neoplasmer
- Sygdomsprogression
- Patologiske tilstande, tegn og symptomer
- Patologisk komplet respons
- Uterine cervikale neoplasmer
Andre undersøgelses-id-numre
- IRB-2026-317(IIT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data will not be shared with external researchers to protect patient privacy and comply with hospital data management regulations.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .