- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07673211
Circulating cfDNA and HPV as Prognostic Biomarkers for First-Line Recurrent Metastatic Cervical Cancer
23. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
60
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
23. juni 2026
Først innsendt som oppfylte QC-kriteriene
23. juni 2026
Først lagt ut (Faktiske)
29. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Patologiske prosesser
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Sykdomsattributter
- Livmorsykdommer
- Kjønnssykdommer, kvinner
- Genitale neoplasmer, kvinnelige
- Livmor livmorhalssykdommer
- Uterine neoplasmer
- Sykdomsprogresjon
- Patologiske tilstander, tegn og symptomer
- Patologisk fullstendig respons
- Uterine cervikale neoplasmer
Andre studie-ID-numre
- IRB-2026-317(IIT)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared with external researchers to protect patient privacy and comply with hospital data management regulations.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .