Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer

NCT05531981 | Unknown

• 1 other identifier: CC-MRD-1
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, a large-scale cohort of cervical cancer patients was established in multiple centers. Minimal residual disease(MRD) was assessed by ddPCR detection of HPV E7 gene ctDNA to assess tumor burden and predict the risk of disease recurrence, so as to provide new biomarkers for precise treatment of cervical cancer patients. The study continued until 36 months after the end of treatment.

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  time from the treatment initiation to disease progression

  up to three years

Secondary Outcomes (3)

• HPV ctDNA state before treatment

  up to three years

• Dynamic change trend of HPV ctDNA after treatment

  up to three years

• Overall Survival

  up to three years

Study Arms (2)

initial surgical treatment group

After the patients were enrolled in the study according to the criteria, they were given standard treatment. The patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, HPV typing test, SCC, CA125, and imaging examination such as CT or MRI if necessary. Peripheral blood samples were collected to detect HPV E7 ctDNA before treatment, 2 weeks after surgery, (1 month after adjuvent radiotherapy if available) and at 6, 12, 18, 24, 30, and 36 months of follow-up.

Other: detect HPV E7 ctDNA

initial concurrent chemoradiotherapy group

After the patients were enrolled in the study according to the criteria, they were given standard treatment. The patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, HPV typing test, SCC, CA125, and imaging examination such as CT or MRI if necessary. Peripheral blood samples were collected to detect HPV E7 ctDNA before treatment, 1 month after radiotherapy and at 6, 12, 18, 24, 30, and 36 months of follow-up.

Other: detect HPV E7 ctDNA

Interventions

detect HPV E7 ctDNA OTHER

Peripheral blood was collected from the patients, and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR

initial concurrent chemoradiotherapy group; initial surgical treatment group

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

Cohort A: Patients with cervical cancer who were initially treated with surgery in Peking Union Medical College Hospital, Peking University Cancer Hospital and Beijing Obstetrics and Gynecology Hospital, capital Medical University were enrolled in this study. Cohort B: Patients who were initially treated with concurrent chemoradiotherapy in Peking Union Medical College Hospital, Peking University Cancer Hospital and Beijing Obstetrics and Gynecology Hospital, capital Medical University were enrolled in this study.

You may qualify if:

• Pathological diagnosis: cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma
• FIGO stage: IA2-IVA
• HPV typing: type 16 or 18
• ECOG 2-0
• The initial treatment was surgery (Cohort A) / concurrent chemoradiotherapy (Cohort B)

You may not qualify if:

• The diagnosis of cervical cancer was made within 3 years of other malignancies
• Pregnant or lactating women
• Refused to sign a consent form

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Obstetrics and Gynecology Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Precision Scientific (Beijing) Co., Ltd: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

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

Central Study Contacts

Yang Xiang

CONTACT

010-69156068; XiangY@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: September 20, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: October 13, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)