Recurrent Cervical CancerNCT04191226
Genetic Mutation in Recurrent Cervical Cancer
An observational study of Recurrent Cervical Cancer and Nucleotide Variant, run by Lei Li at 1 site in China.
Trial summary
Little is known about the characteristics of genetic mutation in recurrent cervical cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Cervical Cancer, Nucleotide Variant, Copy Number Variation
- What is being tested?
- Multi-gene panel testing
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2019to 1 Jan 2023
- 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: Patients of pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma, and aged 18 years or older
Who may be able to join
- Aged 18 years or older
- Pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma
- With available materials for analysis
- With detailed clinicopathological information
- Given consent to participate the trial
Who cannot join
- Not meeting all of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Overall Perspective on the Characteristics of Genetic Mutation in Recurrent Cervical Cancer
Little is known about the characteristics of genetic mutation in recurrent cervical cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. The mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. The total mutation burden (TMB) will be calculated. The status of microsatellite instability, expression of PD-1 and PD-L1 antibodies are also tested. These findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy and immunotherapy.
- Conditions
- Recurrent Cervical Cancer, Nucleotide Variant, Copy Number Variation, Insertion-deletion Variation, Genomic Structural Variation, Total Mutation Burden
- Being tested
- Multi-gene panel testing
- Medical subject headings
- Uterine Cervical Neoplasms, Microsatellite Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-gene panel testingDiagnostic test
A multi-gene panel, which consists of more than 500 hundred genes will be provided for mutation analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of genetic mutations
Frequency of various genetic mutations among recruited patients
Measured: Two years
Secondary outcomes (3)
Total mutation burden
Total mutation burden calculated in definite patient
Measured: Two years
Frequency of microsatellite Instability
Microsatellite Instability in definite patient
Measured: Two years
Expression rates of PD-1 and PD-L1 antibodies
Expression rates of PD-1 and PD-L1 antibodies among recruited patients
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 posted9 Dec 2019
- Study start19 Dec 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191226
- Sponsor's protocol ID
- CC-TMB
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall Perspective on the Characteristics of Genetic Mutation in Recurrent Cervical Cancer
- ClinicalTrials.gov ID
- NCT04191226
- Acronym / sponsor ID
- CC-TMB
- Conditions
- Recurrent Cervical Cancer, Nucleotide Variant, Copy Number Variation, Insertion-deletion Variation, Genomic Structural Variation, Total Mutation Burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 9 Dec 2019 (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.
Little is known about the characteristics of genetic mutation in recurrent cervical cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. The mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. The total mutation burden (TMB) will be calculated. The status of microsatellite instability, expression of PD-1 and PD-L1 antibodies are also tested. These findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy and immunotherapy.
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
- Patients of pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma, and aged 18 years or older
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma
- With available materials for analysis
- With detailed clinicopathological information
- Given consent to participate the trial
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
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 |
|---|---|---|
| Multi-gene panel testingA multi-gene panel, which consists of more than 500 hundred genes will be provided for mutation analysis | Diagnostic test | – |
Primary outcome
Frequency of genetic mutations
Time frame: Two years
Frequency of various genetic mutations among recruited patients
3 secondary outcomes
Total mutation burden
Time frame: Two years
Frequency of microsatellite Instability
Time frame: Two years
Expression rates of PD-1 and PD-L1 antibodies
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 20 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Lei Li principal investigator
Peking Union Medical College Hospital
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 Recurrent Cervical Cancer and Nucleotide Variant, run by Lei Li 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 1 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 20 Dec 2019. 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 Lei 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?
Frequency of genetic mutations (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 20 Dec 2019.