Uterine NeoplasmsNCT06741046
RT for Cervical Adenocarcinoma/adenosquamous Carcinoma
An observational study of Uterine Neoplasms and Genital Neoplasms, Female, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study was to retrospectively analyze patients with cervical adenocarcinoma/adenosquamous carcinoma who had been admitted to our hospital. Approximately 500 cases of cervical adenocarcinoma were planned to be included, summarize the disease characteristics, treatment regimens, and recurrence… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Uterine Neoplasms, Genital Neoplasms, Female
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2014to 1 Jun 2027
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patinets diagnosed with cervical adenocarcinoma or adenosquamous carcinoma receiving CCRT or RT after complete surgery
Who may be able to join
- Pathological diagnosis of cervical adenocarcinoma; b) Age 18-80 years old; c) Karnofsky score≥60 points; e) Complete blood count, and comprehensive metabolic panel meet the conditions for CCRT or RT after surgery; f) No metal implants in the body, and can perform MRI examination; g) Willing to participate in this study and provide written informed consent. -
Who cannot join
- Patients who have received pelvic radiotherapy before;
- Patients whose target tumors have been treated before (chemotherapy, immunotherapy, surgical treatment, etc.);
- Allergy to iodine contrast agent;
- Participating in other clinical studies that may affect the results of this study (determined by the principal investigator);
- Serious diseases that may significantly affect compliance with clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment; g) Other situations that the investigator believes are not suitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Treatment Response and Prognosis of Cervical Adenocarcinoma/adenosquamous Carcinoma After Radiotherapy: a Retrospective Study
The purpose of this study was to retrospectively analyze patients with cervical adenocarcinoma/adenosquamous carcinoma who had been admitted to our hospital. Approximately 500 cases of cervical adenocarcinoma were planned to be included, summarize the disease characteristics, treatment regimens, and recurrence patterns of the patients, and analyze the association between treatment regimens and recurrence patterns and prognosis.
Read the detailed description
This study is a retrospective analysis. The keywords "cervical adenocarcinoma" and "cervical adenosquamous carcinoma" were used to search for patients with cervical adenocarcinoma and cervical adenosquamous carcinoma admitted to the Department of Radiotherapy, Peking Union Medical College Hospital from 2009 to 2024. The clinical information, pathological information, and treatment methods of the patients in the medical records were collected, and the date of death, cancer recurrence, and metastasis were confirmed by querying medical records or conducting telephone interviews. The included cases were divided into the radical surgery group and the concurrent chemoradiotherapy group according to the treatment mode. The pathological types were reclassified according to the IECC 2018 standards, and the associations between pathological types, treatment regimens, recurrence patterns (local recurrence, distant metastasis, recurrence within the irradiation field, recurrence outside the irradiation field), and prognosis were analyzed. For patients with residual local cervical tumors after synchronous chemoradiotherapy or recurrence within the field after radiotherapy, the previous genetic test results of the patients were retrieved, their genomic characteristics were analyzed, and compared with the TCGA database. If the patient has not undergone genetic testing before, pathological sections of the patient will be obtained from our hospital for whole exome sequencing, and the testing items include.
- Conditions
- Uterine Neoplasms, Genital Neoplasms, Female
- Keywords
- cervical adenocarcinoma, cervical adenosquamous carcinoma
- Medical subject headings
- Uterine Neoplasms, Genital Neoplasms, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Radical surgery group | Patients who received radical surgery for cervical cancer in Peking Union Medical College Hospital | |
| Concurrent chemoradiotherapy group | Patients who received concurrent chemoradiotherapy in Peking Union Medical College Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate
Tumor control rate in the cohort after treatment
Measured: local control rates at 2 years or 3 years after the initial treatment
Secondary outcomes (2)
Progress free survival
the time from initial treatment to disease progression or death from any cause.
Measured: 2 years after initial treatment
Overall survival
The length of time from the start of initial treatment to death or the last followup
Measured: 2 years after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jun 2014
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine NeoplasmsStudies 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yanjunfang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741046
- Sponsor's protocol ID
- ATTRACT-Retro
- Status last verified
- Nov 2024
- First submitted
- 16 Dec 2024
- Last updated
- 18 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment Response and Prognosis of Cervical Adenocarcinoma/adenosquamous Carcinoma After Radiotherapy: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06741046
- Acronym / sponsor ID
- ATTRACT-Retro
- Conditions
- Uterine Neoplasms, Genital Neoplasms, Female
- Keywords
- cervical adenocarcinoma, cervical adenosquamous carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Dec 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.
The purpose of this study was to retrospectively analyze patients with cervical adenocarcinoma/adenosquamous carcinoma who had been admitted to our hospital. Approximately 500 cases of cervical adenocarcinoma were planned to be included, summarize the disease characteristics, treatment regimens, and recurrence patterns of the patients, and analyze the association between treatment regimens and recurrence patterns and prognosis.
Detailed description
This study is a retrospective analysis. The keywords "cervical adenocarcinoma" and "cervical adenosquamous carcinoma" were used to search for patients with cervical adenocarcinoma and cervical adenosquamous carcinoma admitted to the Department of Radiotherapy, Peking Union Medical College Hospital from 2009 to 2024. The clinical information, pathological information, and treatment methods of the patients in the medical records were collected, and the date of death, cancer recurrence, and metastasis were confirmed by querying medical records or conducting telephone interviews. The included cases were divided into the radical surgery group and the concurrent chemoradiotherapy group according to the treatment mode. The pathological types were reclassified according to the IECC 2018 standards, and the associations between pathological types, treatment regimens, recurrence patterns (local recurrence, distant metastasis, recurrence within the irradiation field, recurrence outside the irradiation field), and prognosis were analyzed. For patients with residual local cervical tumors after synchronous chemoradiotherapy or recurrence within the field after radiotherapy, the previous genetic test results of the patients were retrieved, their genomic characteristics were analyzed, and compared with the TCGA database. If the patient has not undergone genetic testing before, pathological sections of the patient will be obtained from our hospital for whole exome sequencing, and the testing items include.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical surgery group | – | –Patients who received radical surgery for cervical cancer in Peking Union Medical College Hospital |
| Concurrent chemoradiotherapy group | – | –Patients who received concurrent chemoradiotherapy in Peking Union Medical College Hospital |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patinets diagnosed with cervical adenocarcinoma or adenosquamous carcinoma receiving CCRT or RT after complete surgery
Key inclusion criteria (1 listed)
- Pathological diagnosis of cervical adenocarcinoma; b) Age 18-80 years old; c) Karnofsky score≥60 points; e) Complete blood count, and comprehensive metabolic panel meet the conditions for CCRT or RT after surgery; f) No metal implants in the body, and can perform MRI examination; g) Willing to participate in this study and provide written informed consent. -
Key exclusion criteria (5 listed)
- Patients who have received pelvic radiotherapy before;
- Patients whose target tumors have been treated before (chemotherapy, immunotherapy, surgical treatment, etc.);
- Allergy to iodine contrast agent;
- Participating in other clinical studies that may affect the results of this study (determined by the principal investigator);
- Serious diseases that may significantly affect compliance with clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment; g) Other situations that the investigator believes are not suitable for participation in this clinical study.
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
Local control rate
Time frame: local control rates at 2 years or 3 years after the initial treatment
Tumor control rate in the cohort after treatment
2 secondary outcomes
Progress free survival
Time frame: 2 years after initial treatment
Overall survival
Time frame: 2 years after initial treatment
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 18 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Uterine Neoplasms and Genital Neoplasms, Female, run by Peking Union Medical College Hospital 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 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 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?
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?
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?
Local control rate (time frame: local control rates at 2 years or 3 years after the initial treatment). 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 18 Dec 2024.