Locally Advanced Cervical CancerNCT05602831
Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer
An observational study of Locally Advanced Cervical Cancer, run by Fudan University at 1 site in China.
Trial summary
This observational study is conducted to assess the value of using peripheral blood ctDNA to detect dynamic changes in HPV and genetic variants in predicting the prognosis of patients with locally advanced cervical cancer, as compared with traditional imaging and tumor markers. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- detect HPV and genetic variants
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to Aug 2024
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Cohort A：Patients with initial diagnosis, operable locally advanced cervical cancer, FIGO stage IB2/3-IIA1/2. Cohort B：Patients with initial diagnosis, receive radical chemoradiotherapy locally advanced cervical cancer, FIGO stage IIB-IVA.
Who may be able to join
- Patients with initial diagnosis, operable locally advanced cervical cancer, FIGO stage IB2/3-IIA1/2 or initial diagnosis, receive radical chemoradiotherapy locally advanced cervical cancer, FIGO stage IIB-IVA
- Not receiving systemic treatment
- Pathological diagnosis: cervical squamous cell carcinoma
- Aged 18-70 years
- ECOG PS: 0-1
- Patients volunteer to participate in this study and sign the informed consent, with good compliance, and cooperate with the acquisition of tissue samples and blood samples
Who cannot join
- Patients diagnosed with other malignancies within 5 years
- Patients had received previous systemic antitumor therapy
- In the judgment of the investigator, the patients had other factors that might have caused the study to be discontinued
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200023
Hao Wen, MD, +862164175590 ext. 81000, wenhao@shca.org.cn
About this study
Official title: Using Peripheral Blood Circulating Tumor DNA (ctDNA) Based Human Papillomavirus (HPV) and Genetic Variant Test to Assess the Prognosis of Surgery or Radical Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer
This observational study is conducted to assess the value of using peripheral blood ctDNA to detect dynamic changes in HPV and genetic variants in predicting the prognosis of patients with locally advanced cervical cancer, as compared with traditional imaging and tumor markers.
Read the detailed description
The goal of this study is to assess the prognostic value of ctDNA HPV and gene variant clearance in peripheral blood.
Two cohorts will be enrolled: operable group and radical chemoradiotherapy group.
After enrollment, patients will receive standard treatment and follow-up strategy. Peripheral blood samples will be collected from 2 cohorts of patients before treatment and at different time points after starting treatment. Baseline surgical or puncture tissues will be also obtained.
Peripheral blood ctDNA and baseline tissues will be tested for HPV copy number based on ddPCR and genetic variation based on next-generation sequencing (NGS).
Finally, the correlation of ctDNA HPV and genetic variation clearance with patients prognosis and its value for recurrence monitoring compared to traditional tumor markers and imaging examination will be analyzed.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- detect HPV and genetic variants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detect HPV and genetic variantsOther
Serum tumor markers and ctDNA HPV and genetic variants will be detected in peripheral blood samples. HPV and genetic variants will be also detected in baseline surgical tissues.
detect HPV and genetic variantsOther
Serum tumor markers and ctDNA HPV and genetic variants will be detected in peripheral blood samples. HPV and genetic variants will be also detected in baseline puncture tissues.
| Study group | Role | What they receive |
|---|---|---|
| operable treatment group | After enrollment, patients will receive standard treatment and conventional follow-up strategy.
Peripheral blood samples will be collected before treatment and at different time points after starting treatment.
Baseline surgical tissue will be also obtained. Receives: Other: detect HPV and genetic variants | |
| radical chemoradiotherapy group | After enrollment, patients will receive standard treatment and conventional follow-up strategy.
Peripheral blood samples will be collected before treatment and at different time points after starting treatment.
Baseline puncture tissue will be also obtained before radical chemoradiotherapy. Receives: Other: detect HPV and genetic variants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Assess PFS in ctDNA HPV and genetic variants clearance versus not clearance
Measured: Two years
Secondary outcomes (2)
Overall Survival (OS)
Assess OS in ctDNA HPV and genetic variants clearance versus not clearance
Measured: Two years
Recurrence prediction performance of ctDNA dynamic changes
Performance of dynamic changes of HPV copy number and genetic variation in ctDNA in predicting recurrence compared with imaging and serum tumor markers
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start10 Aug 2022
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Amoy Diagnostics
- Responsible party
- Principal investigator, Xiaohua Wu MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602831
- Sponsor's protocol ID
- LACC-BD-1
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2022
- Last updated
- 2 Nov 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Peripheral Blood Circulating Tumor DNA (ctDNA) Based Human Papillomavirus (HPV) and Genetic Variant Test to Assess the Prognosis of Surgery or Radical Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT05602831
- Acronym / sponsor ID
- LACC-BD-1
- Conditions
- Locally Advanced Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Amoy Diagnostics
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 2 Nov 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.
This observational study is conducted to assess the value of using peripheral blood ctDNA to detect dynamic changes in HPV and genetic variants in predicting the prognosis of patients with locally advanced cervical cancer, as compared with traditional imaging and tumor markers.
Detailed description
The goal of this study is to assess the prognostic value of ctDNA HPV and gene variant clearance in peripheral blood.
Two cohorts will be enrolled: operable group and radical chemoradiotherapy group.
After enrollment, patients will receive standard treatment and follow-up strategy. Peripheral blood samples will be collected from 2 cohorts of patients before treatment and at different time points after starting treatment. Baseline surgical or puncture tissues will be also obtained.
Peripheral blood ctDNA and baseline tissues will be tested for HPV copy number based on ddPCR and genetic variation based on next-generation sequencing (NGS).
Finally, the correlation of ctDNA HPV and genetic variation clearance with patients prognosis and its value for recurrence monitoring compared to traditional tumor markers and imaging examination will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| operable treatment group | – | Other: detect HPV and genetic variantsAfter enrollment, patients will receive standard treatment and conventional follow-up strategy. Peripheral blood samples will be collected before treatment and at different time points after starting treatment. Baseline surgical tissue will be also obtained. |
| radical chemoradiotherapy group | – | Other: detect HPV and genetic variantsAfter enrollment, patients will receive standard treatment and conventional follow-up strategy. Peripheral blood samples will be collected before treatment and at different time points after starting treatment. Baseline puncture tissue will be also obtained before radical chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort A：Patients with initial diagnosis, operable locally advanced cervical cancer, FIGO stage IB2/3-IIA1/2. Cohort B：Patients with initial diagnosis, receive radical chemoradiotherapy locally advanced cervical cancer, FIGO stage IIB-IVA.
Key inclusion criteria (6 listed)
- Patients with initial diagnosis, operable locally advanced cervical cancer, FIGO stage IB2/3-IIA1/2 or initial diagnosis, receive radical chemoradiotherapy locally advanced cervical cancer, FIGO stage IIB-IVA
- Not receiving systemic treatment
- Pathological diagnosis: cervical squamous cell carcinoma
- Aged 18-70 years
- ECOG PS: 0-1
Key exclusion criteria (3 listed)
- Patients diagnosed with other malignancies within 5 years
- Patients had received previous systemic antitumor therapy
- In the judgment of the investigator, the patients had other factors that might have caused the study to be discontinued
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 and genetic variantsSerum tumor markers and ctDNA HPV and genetic variants will be detected in peripheral blood samples. HPV and genetic variants will be also detected in baseline surgical tissues. | Other | operable treatment group |
| detect HPV and genetic variantsSerum tumor markers and ctDNA HPV and genetic variants will be detected in peripheral blood samples. HPV and genetic variants will be also detected in baseline puncture tissues. | Other | radical chemoradiotherapy group |
Primary outcome
Progression Free Survival (PFS)
Time frame: Two years
Assess PFS in ctDNA HPV and genetic variants clearance versus not clearance
2 secondary outcomes
Overall Survival (OS)
Time frame: Two years
Recurrence prediction performance of ctDNA dynamic changes
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 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 Locally Advanced Cervical Cancer, run by Fudan University 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 6 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 2 Nov 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 Hao Wen, MD (+86-021-64175590 ext. 81000, wenhao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Two 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 2 Nov 2022.