Genital Neoplasms, FemaleNCT07015593
Patient Journey in Advanced Gynecologic Cancers
An observational study of Genital Neoplasms, Female and Uterine Cervical Neoplasms, run by Tongji Hospital at 4 sites in China.
Trial summary
This is a mixed-methods survey study including a 2-phased sequential-explanatory design. This study is to understand the patient journey in conventional therapy for newly diagnosed stage III or IV CC or EC in China, including ①patients' treatment decision making factors and treatment experiences and ② patients' unmet… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genital Neoplasms, Female, Uterine Cervical Neoplasms, Endometrial Carcinoma
- What is being tested?
- interview
- How many people
- 780 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jul 2025to 30 Nov 2026
- How long will I take part?
- 1 Day
- 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: It is estimated that ~780 patients will be included in this study. For qualitative insights, previous studies have shown that a minimum of 12 respondents (Guest et al. 2006) is required to reach data saturation. A sample size of ~30 will be sufficient to gather qualitative insights and attain saturation. For quantitative survey, considering most of the variables in quantitative survey are categorical variables, we tend to use 50% in the sample size formula since it will provide us with the maximum sample size required for any question, we calculated the sample size to be ~750 with a confidence interval of 95% and margin of error 5%. The number of specific experts interviewed may be fine-tuned depending on actual implementation.
Who may be able to join
- Age 18 or older
- Newly diagnosed stage III or IV CC or EC
- Completed their initial conventional therapies which must include at least chemotherapy, radiotherapy or a combination between Dec. 2022 to Dec. 2024 and the therapies were within 6 months after diagnosis.
- Told by their physician that their disease is stable.
- Patients must have informed consent form (ICF) signed for the study.
Who cannot join
- Previously treated with targeted biologic therapy anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
- Previously participated in or participating in a clinical trial.
- Patients who received another line of therapy after initial therapy.
- Unable or unwilling to provide informed consent.
- Not fluent in local language.
- Indicates or exhibits hearing difficulties, which would make a conversation challenging.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Dongling Zou
Chongqing, 430030
Dongling Zou, ph.D, 086-023-65301682, cqzl_zdl@163.com
Shuzhong Yao
Guangzhou, Guangdong, 510080
Shuzhong Yao, ph.D, 086-020-87755766, yszlfy@163.com
Ying Zhou
Hefei, Anhui, 230001
Ying Zhou, PhD, 13865901025, caddie1234@gmail.com
Gang Chen
Wuhan, Hubei, 430030
Gang Chen, 086-027-83662681, tjchengang@hust.edu.cn
Yingjie Hu, 086-027-83662681, huyj@hust.edu.cn
About this study
Official title: Patient Journey in Conventional Therapy for Primarily Treated Advanced Gynecologic Cancers in China
This is a mixed-methods survey study including a 2-phased sequential-explanatory design. This study is to understand the patient journey in conventional therapy for newly diagnosed stage III or IV CC or EC in China, including ①patients' treatment decision making factors and treatment experiences and ② patients' unmet needs during post-treatment surveillance.
Read the detailed description
This is a mixed-methods survey study including a 2-phased sequential-explanatory design: Phase 1, Qualitative interview will be done first to explore the treatment decision factors, treatment experiences and unmet needs during post treatment surveillance, to provide components and inform the quantitative data collection. Phase 2, quantitative survey to collect data on a larger scale and allow a statistical generation of the qualitative findings.
- Being tested
- interview
- Medical subject headings
- Genital Neoplasms, Female, Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
30 for Qualitative interview and 750 for quantitative survey
| Study group | Role | What they receive |
|---|---|---|
| experimental group | 780 patients for interview Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment decision making
- Information seeking in treatment decision
- Treatment decision making factors
- Clinical trial awareness
Measured: 1 day. At the time of the interview.
Initial treatment experiences
- Influence of treatment on daily life and work
- Information and education during treatment
- Coordination of care
- Overall impression on care received and doctor/nurses' availability
Measured: 1 day. At the time of the interview.
Unmet needs and gaps from diagnosis to post-treatment surveillance
- Psychological and emotional needs
- Social support needs
- Healthcare needs
- Gaps during follow-up care
Measured: 1 day. At the time of the interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Neoplasms, FemaleStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Other
- Time perspective
- Prospective
- Enrolment
- 780 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Chen (101199), Tongji Hospital
- Investigators
- Gang Chen, PhD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015593
- Sponsor's protocol ID
- NIS103233
- Other IDs
- [2024]S257
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Journey in Conventional Therapy for Primarily Treated Advanced Gynecologic Cancers in China
- ClinicalTrials.gov ID
- NCT07015593
- Acronym / sponsor ID
- NIS103233
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 11 Jun 2025 (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 is a mixed-methods survey study including a 2-phased sequential-explanatory design. This study is to understand the patient journey in conventional therapy for newly diagnosed stage III or IV CC or EC in China, including ①patients' treatment decision making factors and treatment experiences and ② patients' unmet needs during post-treatment surveillance.
Detailed description
This is a mixed-methods survey study including a 2-phased sequential-explanatory design: Phase 1, Qualitative interview will be done first to explore the treatment decision factors, treatment experiences and unmet needs during post treatment surveillance, to provide components and inform the quantitative data collection. Phase 2, quantitative survey to collect data on a larger scale and allow a statistical generation of the qualitative findings.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: interview780 patients for interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is estimated that ~780 patients will be included in this study. For qualitative insights, previous studies have shown that a minimum of 12 respondents (Guest et al. 2006) is required to reach data saturation. A sample size of ~30 will be sufficient to gather qualitative insights and attain saturation. For quantitative survey, considering most of the variables in quantitative survey are categorical variables, we tend to use 50% in the sample size formula since it will provide us with the maximum sample size required for any question, we calculated the sample size to be ~750 with a confidence interval of 95% and margin of error 5%. The number of specific experts interviewed may be fine-tuned depending on actual implementation.
Key inclusion criteria (5 listed)
- Age 18 or older
- Newly diagnosed stage III or IV CC or EC
- Completed their initial conventional therapies which must include at least chemotherapy, radiotherapy or a combination between Dec. 2022 to Dec. 2024 and the therapies were within 6 months after diagnosis.
- Told by their physician that their disease is stable.
- Patients must have informed consent form (ICF) signed for the study.
Key exclusion criteria (6 listed)
- Previously treated with targeted biologic therapy anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
- Previously participated in or participating in a clinical trial.
- Patients who received another line of therapy after initial therapy.
- Unable or unwilling to provide informed consent.
- Not fluent in local language.
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 |
|---|---|---|
| interview30 for Qualitative interview and 750 for quantitative survey | Other | experimental group |
Primary outcome
Treatment decision making
Time frame: 1 day. At the time of the interview.
1. Information seeking in treatment decision 2. Treatment decision making factors 3. Clinical trial awareness
Initial treatment experiences
Time frame: 1 day. At the time of the interview.
1. Influence of treatment on daily life and work 2. Information and education during treatment 3. Coordination of care 4. Overall impression on care received and doctor/nurses' availability
Unmet needs and gaps from diagnosis to post-treatment surveillance
Time frame: 1 day. At the time of the interview.
1. Psychological and emotional needs 2. Social support needs 3. Healthcare needs 4. Gaps during follow-up care
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 11 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Gang Chen, PhD principal investigator
Tongji Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Neoplasms, Female and Uterine Cervical Neoplasms, run by Tongji Hospital at 4 sites 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 6 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 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Gang Chen (086-027-83662681, tjchengang@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment decision making (time frame: 1 day. At the time of the interview.). The study lists 3 primary outcomes in all. 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 11 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.