Cervical CancerNCT05188716
Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer
An observational study of Cervical Cancer and Benign Tumor of Uterus, run by Chuangzhen Chen at 1 site in China.
Trial summary
This study aims to investigate mechanisms that dictate tumor immunogenicity and to explore potential biomarkers that could help predict changes of tumor immunogenicity and therapeutic response in patients with cervical cancer after chemoradiotherapy or surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Cancer, Benign Tumor of Uterus
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2020to 15 Jan 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients proven diagnosis of cervical cancer or benign gynecologic tumor and will have radiotherapy as part of their therapeutic regimens or will undergo surgery in Cancer Hospital of Shantou University Medical College.
Who may be able to join
- Pathological proven diagnosis of cervical cancer or benign gynecologic tumor and will undergoing panhysterectomy or pathological proven diagnosis of cervical cancer and will undergoing radiotherapy
- Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery
- Patient must provide study-specific informed consent prior to study entry
Who cannot join
- History of autoimmune diseases
- History of immunotherapy
- History of pelvic radiotherapy
- Will receive immunotherapy during the course of treatment
- Contraindications for biopsy, such as high bleeding risk
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031
About this study
Official title: Investigating Mechanisms That Dictates Tumor Immunogenicity and Exploring Biomarkers That Could Help Predict the Anti-tumor Immune Response in Patients With Cervical Cancer
This study aims to investigate mechanisms that dictate tumor immunogenicity and to explore potential biomarkers that could help predict changes of tumor immunogenicity and therapeutic response in patients with cervical cancer after chemoradiotherapy or surgery.
Read the detailed description
Patients pathologically confirmed with cervical cancer or benign gynecologic tumor that requires chemoradiotherapy or surgery will be recruited to this study. Tumor samples, normal epithelium of the cervix or other biological samples will be obtained from patients who will receive surgery to establish the baseline status of tumor/mucosal immunogeneicity. For patients undergoing definite radiotherapy, tumor biopsies, collection of blood samples and microbiota will be performed before and during the course of treatment and when the disease progressed. These biological specimens will be used to investigate signaling pathways that determine tumor immungenenicity and their dynamic changes during treatment and to explore feasible biomarkers that could reflect and help monitor the inter- and intra-patient varariation of tumor immunogenicity.
- Conditions
- Cervical Cancer, Benign Tumor of Uterus
- Keywords
- Cervical cancer, Tumor immunogenicity
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression status of biomarkers during treatment and follow-up
Expression status of biomarkers in patients' biological specimens through the course of treatment and during follow-up as assessed by a variety of means, including RNA-seq, DNA-seq, RT-qPCR, IHC, WB, flow cytometry and ELISA.
Measured: From the date of enrollment until the date of disease progression, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Dec 2020
- Primary completion13 Oct 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuangzhen Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chuangzhen Chen, Shantou University Medical College
- Investigators
- Chuangzhen Chen, MD, Principal investigator, Affiliated Cancer Hospital of Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188716
- Sponsor's protocol ID
- Immune002
- Status last verified
- Feb 2024
- First submitted
- 20 May 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Mechanisms That Dictates Tumor Immunogenicity and Exploring Biomarkers That Could Help Predict the Anti-tumor Immune Response in Patients With Cervical Cancer
- ClinicalTrials.gov ID
- NCT05188716
- Acronym / sponsor ID
- Immune002
- Conditions
- Cervical Cancer, Benign Tumor of Uterus
- Keywords
- Cervical cancer, Tumor immunogenicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chuangzhen ChenUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 12 Jan 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 study aims to investigate mechanisms that dictate tumor immunogenicity and to explore potential biomarkers that could help predict changes of tumor immunogenicity and therapeutic response in patients with cervical cancer after chemoradiotherapy or surgery.
Detailed description
Patients pathologically confirmed with cervical cancer or benign gynecologic tumor that requires chemoradiotherapy or surgery will be recruited to this study. Tumor samples, normal epithelium of the cervix or other biological samples will be obtained from patients who will receive surgery to establish the baseline status of tumor/mucosal immunogeneicity. For patients undergoing definite radiotherapy, tumor biopsies, collection of blood samples and microbiota will be performed before and during the course of treatment and when the disease progressed. These biological specimens will be used to investigate signaling pathways that determine tumor immungenenicity and their dynamic changes during treatment and to explore feasible biomarkers that could reflect and help monitor the inter- and intra-patient varariation of tumor immunogenicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients proven diagnosis of cervical cancer or benign gynecologic tumor and will have radiotherapy as part of their therapeutic regimens or will undergo surgery in Cancer Hospital of Shantou University Medical College.
Key inclusion criteria (3 listed)
- Pathological proven diagnosis of cervical cancer or benign gynecologic tumor and will undergoing panhysterectomy or pathological proven diagnosis of cervical cancer and will undergoing radiotherapy
- Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery
- Patient must provide study-specific informed consent prior to study entry
Key exclusion criteria (5 listed)
- History of autoimmune diseases
- History of immunotherapy
- History of pelvic radiotherapy
- Will receive immunotherapy during the course of treatment
- Contraindications for biopsy, such as high bleeding risk
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
Expression status of biomarkers during treatment and follow-up
Time frame: From the date of enrollment until the date of disease progression, assessed up to 5 years
Expression status of biomarkers in patients' biological specimens through the course of treatment and during follow-up as assessed by a variety of means, including RNA-seq, DNA-seq, RT-qPCR, IHC, WB, flow cytometry and ELISA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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. This study is not recruiting at the moment.
Chuangzhen Chen, MD principal investigator
Affiliated Cancer Hospital of Shantou University Medical College
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 Cervical Cancer and Benign Tumor of Uterus, run by Chuangzhen Chen 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 6 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression status of biomarkers during treatment and follow-up (time frame: From the date of enrollment until the date of disease progression, assessed up to 5 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 6 Feb 2024.