Uterine Cervical NeoplasmsNCT05531981
Detection of Minimal Residual Disease Based on HPV ctDNA in Cervical Cancer
An observational study of Uterine Cervical Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- detect HPV E7 ctDNA
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2022to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- The diagnosis of cervical cancer was made within 3 years of other malignancies
- Pregnant or lactating women
- Refused to sign a consent form
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yang Xiang, 01069156068, XiangY@pumch.cn
About this study
Official title: Clinical Value of Minimal Residual Disease Detection Based on Human Papillomavirus Circulating Tumor DNA (HPV ctDNA) in Cervical Cancer
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.
Read the detailed description
The purpose of this study is to assess MRD by detecting HPV E7 gene ctDNA to assess tumor burden and predict the risk of disease recurrence. According to the treatment methods, the patients were divided into two groups :(1) initial surgical treatment group (2) 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, after treatment, and at 6, 12, 18, 24, 30, and 36 months of follow-up.
The primary endpoint is Disease-free survival (DFS, time from the treatment initiation to disease progression). Secondary endpoints include HPV ctDNA state before treatment, dynamic change trend of HPV ctDNA after treatment and overall survival (OS, time from the treatment initiation to death).
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- detect HPV E7 ctDNA
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detect HPV E7 ctDNAOther
Peripheral blood was collected from the patients, and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: detect HPV E7 ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
time from the treatment initiation to disease progression
Measured: up to three years
Secondary outcomes (3)
HPV ctDNA state before treatment
Peripheral blood was collected from the patients before treatment (surgery or chemotherapy), and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR
Measured: up to three years
Dynamic change trend of HPV ctDNA after treatment
Peripheral blood was collected from the patients after treatment ((2 weeks after surgery), 1 month after radiotherapy and at 6, 12, 18, 24, 30, and 36 months of follow-up), and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR
Measured: up to three years
Overall Survival
time from the treatment initiation to death
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start20 Sep 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital, Peking University Cancer Hospital & Institute, Precision Scientific (Beijing) Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531981
- Sponsor's protocol ID
- CC-MRD-1
- Status last verified
- Aug 2022
- First submitted
- 4 Sep 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Minimal Residual Disease Detection Based on Human Papillomavirus Circulating Tumor DNA (HPV ctDNA) in Cervical Cancer
- ClinicalTrials.gov ID
- NCT05531981
- Acronym / sponsor ID
- CC-MRD-1
- Conditions
- Uterine Cervical Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital, Peking University Cancer Hospital & Institute, Precision Scientific (Beijing) Co., Ltd
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to assess MRD by detecting HPV E7 gene ctDNA to assess tumor burden and predict the risk of disease recurrence. According to the treatment methods, the patients were divided into two groups :(1) initial surgical treatment group (2) 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, after treatment, and at 6, 12, 18, 24, 30, and 36 months of follow-up.
The primary endpoint is Disease-free survival (DFS, time from the treatment initiation to disease progression). Secondary endpoints include HPV ctDNA state before treatment, dynamic change trend of HPV ctDNA after treatment and overall survival (OS, time from the treatment initiation to death).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| initial surgical treatment group | – | Other: detect HPV E7 ctDNAAfter 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. |
| initial concurrent chemoradiotherapy group | – | Other: detect HPV E7 ctDNAAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- The diagnosis of cervical cancer was made within 3 years of other malignancies
- Pregnant or lactating women
- Refused to sign a consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| detect HPV E7 ctDNAPeripheral blood was collected from the patients, and the copy number of HPV E7 gene in ctDNA was accurately detected by ddPCR | Other | initial concurrent chemoradiotherapy group, initial surgical treatment group |
Primary outcome
Disease-free survival
Time frame: up to three years
time from the treatment initiation to disease progression
3 secondary outcomes
HPV ctDNA state before treatment
Time frame: up to three years
Dynamic change trend of HPV ctDNA after treatment
Time frame: up to three years
Overall Survival
Time frame: up to three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Xiang (010-69156068, XiangY@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: up to three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.