ImmunotherapyNCT06649838
Customized Circulating Tumor DNA Testing for Cervical Cancer Recurrence Surveillance and Treatment Decisions
An observational study of Immunotherapy and Cervical Cancer, run by Peking Union Medical College Hospital.
Trial summary
Immunotherapy is the main option for advanced, recurrent and metastatic cervical cancer. However, due to the complex interaction between the immune system and tumors, there is still a lack of effective markers for immunotherapy. Scientists are actively searching for and developing new immunotherapy markers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Immunotherapy, Cervical Cancer, CtDNA
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 2 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: A total of 60 patients with cervical cancer were enrolled, including 10 patients with local advanced cervical cancer (IB3-IIB) and 20 patients with advanced cervical cancer (10 patients with stage IIIC and 10 patients with stage IV). The second team consisted of 30 patients with recurrent cervical cancer.
Who may be able to join
- be willing and able to provide written informed consent/consent for the trial.
- Be 18 years of age or older on the date of signing the informed consent form.
- patients with histologically or cytologically documented locally advanced, advanced, or first recurrent cervical cancer. For treatment-naive patients, 4) no previous cancer treatment including chemotherapy or radiotherapy; Patients with an initial recurrence had not received any other cancer treatment, including chemotherapy or radiotherapy, after the diagnosis of an initial recurrence before enrollment.
- 5) measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- 6) willing and able to provide tumor lesions or excisional biopsy tissue. 7) a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. Demonstrate adequate organ function.
- 8) a negative pregnancy test in a fertile female patient.
Who cannot join
- be diagnosed as immunocompromised or receiving systemic steroid therapy or any other form of immunosuppressive therapy.
- a known history of active tuberculosis (Mycobacterium tuberculosis).
- have a known other malignancy that is progressing or requires active treatment.
- known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- have an active autoimmune disease requiring systemic treatment within the past 2 years.
- known history or any evidence of active noninfectious pneumonia.
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- active infection requiring systemic therapy.
- there is historical or current evidence of any condition, treatment, or laboratory abnormality that could confound the trial results, interfere with the patient's participation throughout the trial, or that the treatment investigator believes participation would not be in the patient's best interest.
- psychiatric or substance abuse disorders known to interfere with compliance with trial requirements.
- be pregnant or breastfeeding, or expect to become pregnant or give birth to a child within the intended duration of the trial.
- had a known history of human immunovirus (HIV) (HIV 1/2 antibodies).
- known to have active hepatitis B (e.g., HBsAg reactive) or hepatitis C.
- received live vaccine within 30 days of planned initiation of study treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Immunotherapy is the main option for advanced, recurrent and metastatic cervical cancer. However, due to the complex interaction between the immune system and tumors, there is still a lack of effective markers for immunotherapy. Scientists are actively searching for and developing new immunotherapy markers. For cervical cancer diagnosis, it has been shown that ctDNA mutations can reflect HPV integration sites. In terms of cervical cancer prognosis monitoring, cohort studies focused on the application of HPV ctDNA in the field of cervical cancer prognosis monitoring. The aim of this study is to design a customized ctDNA probe for cancer patients through a priori tumor detection method, and to guide recurrence monitoring plan and implement individualized adjuvant therapy according to the results, and to explore personalized biomarkers to guide cervical cancer immunotherapy. To explore the possibility of customized ctDNA detection as a diagnostic marker for cervical cancer. To explore the predictive and prognostic value of customized ctDNA dynamic monitoring. A multi-arm cohort clinical study is planned. To comprehensively study the treatment strategy of advanced and recurrent cervical cancer and explore the related biomarkers through the customized dynamic monitoring of ctDNA in patients with advanced and recurrent cervical cancer. A total of 60 patients with cervical cancer were enrolled.
- Conditions
- Immunotherapy, Cervical Cancer, CtDNA, Biomarker
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatic mutation detection by WES
Measured: from Des 2024 to Oct 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start20 Dec 2024 (estimated)
- Primary completion2 Mar 2025 (estimated)
- Study completion2 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649838
- Sponsor's protocol ID
- RCC-ctDNA
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Circulating Tumor DNA Testing for Cervical Cancer Recurrence Surveillance and Treatment Decisions
- ClinicalTrials.gov ID
- NCT06649838
- Acronym / sponsor ID
- RCC-ctDNA
- Conditions
- Immunotherapy, Cervical Cancer, CtDNA, Biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 2 Mar 2025 (estimated)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 21 Oct 2024 (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.
Immunotherapy is the main option for advanced, recurrent and metastatic cervical cancer. However, due to the complex interaction between the immune system and tumors, there is still a lack of effective markers for immunotherapy. Scientists are actively searching for and developing new immunotherapy markers. For cervical cancer diagnosis, it has been shown that ctDNA mutations can reflect HPV integration sites. In terms of cervical cancer prognosis monitoring, cohort studies focused on the application of HPV ctDNA in the field of cervical cancer prognosis monitoring. The aim of this study is to design a customized ctDNA probe for cancer patients through a priori tumor detection method, and to guide recurrence monitoring plan and implement individualized adjuvant therapy according to the results, and to explore personalized biomarkers to guide cervical cancer immunotherapy. To explore the possibility of customized ctDNA detection as a diagnostic marker for cervical cancer. To explore the predictive and prognostic value of customized ctDNA dynamic monitoring. A multi-arm cohort clinical study is planned. To comprehensively study the treatment strategy of advanced and recurrent cervical cancer and explore the related biomarkers through the customized dynamic monitoring of ctDNA in patients with advanced and recurrent cervical cancer. A total of 60 patients with cervical cancer were enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 60 patients with cervical cancer were enrolled, including 10 patients with local advanced cervical cancer (IB3-IIB) and 20 patients with advanced cervical cancer (10 patients with stage IIIC and 10 patients with stage IV). The second team consisted of 30 patients with recurrent cervical cancer.
Key inclusion criteria (6 listed)
- be willing and able to provide written informed consent/consent for the trial.
- Be 18 years of age or older on the date of signing the informed consent form.
- patients with histologically or cytologically documented locally advanced, advanced, or first recurrent cervical cancer. For treatment-naive patients, 4) no previous cancer treatment including chemotherapy or radiotherapy; Patients with an initial recurrence had not received any other cancer treatment, including chemotherapy or radiotherapy, after the diagnosis of an initial recurrence before enrollment.
- 5) measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- 6) willing and able to provide tumor lesions or excisional biopsy tissue. 7) a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. Demonstrate adequate organ function.
Key exclusion criteria (13 listed)
- be diagnosed as immunocompromised or receiving systemic steroid therapy or any other form of immunosuppressive therapy.
- a known history of active tuberculosis (Mycobacterium tuberculosis).
- have a known other malignancy that is progressing or requires active treatment.
- known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- have an active autoimmune disease requiring systemic treatment within the past 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Somatic mutation detection by WES
Time frame: from Des 2024 to Oct 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunotherapy and Cervical Cancer, run by Peking Union Medical College Hospital.
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 13 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: opening soon, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatic mutation detection by WES (time frame: from Des 2024 to Oct 2026). 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 19 Dec 2024.