Cervical CancerNCT06238284
HER2 Expression in Gynecological Malignant Tumors in Chongqing Area of China
An observational study of Cervical Cancer and Endometrial Cancer, run by Chongqing University Cancer Hospital.
Trial summary
This study aims to retrospectively analyze the HER2 expression of gynecological malignant tumors in Chongqing by immunohistochemical detection, and explore the correlation between HER2 level, therapy response and prognosis based on patient clinical information. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 26 Jan 2024to 31 May 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with cervical adenocarcinoma (including carcinosarcoma), adenocarcinoma of uterus (including carcinosarcoma), or ovarian cancer, etc.
Who may be able to join
- Patients with primary gynecological malignant tumor confirmed by histopathology
- Women aged 18-75
- The expected survival time is greater than 12 weeks
- KPS > 60, ECOG score is 0-2
- All subjects voluntarily joined this study with informed consents, and had good compliance of follow-up
Who cannot join
- Pregnant and lactating women
- Suffering from other malignant tumors in the past 5 years
- Patients who are not suitable for this study according to the investigator's judgment
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to retrospectively analyze the HER2 expression of gynecological malignant tumors in Chongqing by immunohistochemical detection, and explore the correlation between HER2 level, therapy response and prognosis based on patient clinical information.
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer, HER2 Expression
- Being tested
- no intervention
- Keywords
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer, HER2 Expression, Therapeutic efficacy, Prognosis
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Since it is a retrospective study, no intervention is needed.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cancer Group | Not described Receives: Other: no intervention | |
| Endometrial Cancer Group | Not described Receives: Other: no intervention | |
| Ovarian Cancer Group | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HER2 status
HER2 exprssion level evaluated by pathologists
Measured: from 2023.07 to 2024.05
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start26 Jan 2024 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 May 2024 (estimated)
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238284
- Sponsor's protocol ID
- CQ-HER2-GYN
- Status last verified
- Jun 2023
- First submitted
- 25 Jan 2024
- Last updated
- 2 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER2 Expression in Gynecological Malignant Tumors in Chongqing Area of China
- ClinicalTrials.gov ID
- NCT06238284
- Acronym / sponsor ID
- CQ-HER2-GYN
- Conditions
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer, HER2 Expression
- Keywords
- Cervical Cancer, Endometrial Cancer, Ovarian Cancer, HER2 Expression, Therapeutic efficacy, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 26 Jan 2024 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 2 Feb 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.
This study aims to retrospectively analyze the HER2 expression of gynecological malignant tumors in Chongqing by immunohistochemical detection, and explore the correlation between HER2 level, therapy response and prognosis based on patient clinical information.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervical Cancer Group | – | Other: no intervention |
| Endometrial Cancer Group | – | Other: no intervention |
| Ovarian Cancer Group | – | Other: no intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with cervical adenocarcinoma (including carcinosarcoma), adenocarcinoma of uterus (including carcinosarcoma), or ovarian cancer, etc.
Key inclusion criteria (5 listed)
- Patients with primary gynecological malignant tumor confirmed by histopathology
- Women aged 18-75
- The expected survival time is greater than 12 weeks
- KPS > 60, ECOG score is 0-2
- All subjects voluntarily joined this study with informed consents, and had good compliance of follow-up
Key exclusion criteria (3 listed)
- Pregnant and lactating women
- Suffering from other malignant tumors in the past 5 years
- Patients who are not suitable for this study according to the investigator's judgment
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 |
|---|---|---|
| no interventionSince it is a retrospective study, no intervention is needed. | Other | Cervical Cancer Group, Endometrial Cancer Group, Ovarian Cancer Group |
Primary outcome
HER2 status
Time frame: from 2023.07 to 2024.05
HER2 exprssion level evaluated by pathologists
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Endometrial Cancer, run by Chongqing University Cancer 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 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 2 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Zhou, PH.D (13708384529, qizhou9128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HER2 status (time frame: from 2023.07 to 2024.05). 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 Feb 2024.