Detecting minimal residual disease in cervical cancer using HPV ctDNA
Clinical Value of Minimal Residual Disease Detection Based on Human Papillomavirus Circulating Tumor DNA (HPV ctDNA) in Cervical Cancer
This study is testing if a new method to find leftover cancer DNA in the blood can help doctors better track and treat cervical cancer patients after their initial treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05531981 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess minimal residual disease (MRD) in cervical cancer patients by detecting HPV E7 gene circulating tumor DNA (ctDNA). A large cohort of patients is established across multiple centers, with participants divided into two groups based on their initial treatment: surgical treatment or concurrent chemoradiotherapy. Patients will undergo regular follow-ups and various examinations over a period of up to 36 months post-treatment to monitor disease progression and survival outcomes. The study seeks to provide new biomarkers for precise treatment and predict the risk of disease recurrence.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma at FIGO stages IA2-IVA who are HPV type 16 or 18 positive.
Not a fit: Patients with a history of other malignancies diagnosed within the last three years or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for cervical cancer patients, potentially reducing the risk of recurrence.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer, suggesting that this approach may be beneficial, although the specific application in cervical cancer is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * The diagnosis of cervical cancer was made within 3 years of other malignancies * Pregnant or lactating women * Refused to sign a consent form
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yang Xiang
- Email: XiangY@pumch.cn
- Phone: 010-69156068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.