Clinical Characters of the Diagnosis and Treatment of Gynecological Malignant Tumors in China : A Real World Study

October 6, 2021 updated by: Qinglei Gao, Tongji Hospital

Gynecological tumors are serious threats to women's health. Ovarian Cancer (OC), uterine and cervical malignancies (c-uc) are common gynecological malignancies, which are featured by high morbidity and mortality, limited late-stage efficacy, easy recurrence and drug resistance.

Real World Study (RWS) refers to the study based on a large sample size (covering representative subjects), according to the actual condition, carry out evaluation for a long time, and pay attention to the outcome of treatment, meaningful to further evaluate external validity and safety of the intervention measures.

this study is devoted to the provide the real world evidence for the clinical treatment of gynecological malignant tumors in China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Randomized clinical trials（RCT）are representative traditional clinical studies with high internal validity but limited external validity. Originated in the effectiveness of clinical trials, Real World Study (RWS) refers to the study based on a large sample size (covering representative subjects), according to the actual condition and will not randomly chosen treatment measures, carry out evaluation for a long time, and pay attention to the outcome of treatment, meaningful to further evaluate external validity and safety of the intervention measures. The real world research covers the etiology, diagnosis, treatment and prognosis, providing the maximum reference for the diagnosis and treatment of clinical patients. Now the application of RWS in oncology is getting more and more attention. In the current information era, Big Data (BD) technology is gradually applied and popularized. To build a disease database platform, collect, manage and process big data in the diagnosis and treatment process in the real world, and conduct RWS on the basis of the platform, will be of great enlightenment to clinical practice.

Gynecological tumors are serious threats to women's health. Ovarian Cancer (OC), uterine and cervical malignancies (c-uc) are common gynecological malignancies, which are featured by high morbidity and mortality, limited late-stage efficacy, easy recurrence and drug resistance, etc., causing serious difficulties to gynecological oncologists and scholars. Asia is one of the regions with high incidence of ovarian cancer, uterine body malignancy and cervical cancer. In China, the incidence of uterine body malignancies including endometrial cancer and rare gynecological tumors (such as ovarian sarcoma, endometrial sarcoma, transparent cell carcinoma, etc.) is increasing. New cases and deaths from ovarian cancer remain high. At present, no effective early screening and diagnosis method has been found, and the recurrence rate is high after treatment, and the prognosis of patients is poor.At present, the standard treatment for ovarian cancer is surgery, supplemented by postoperative chemotherapy. At present, researches at home and abroad mainly focus on the advantages and disadvantages of neo-adjuvant chemotherapy, molecular targeted therapy, secondary surgery for tumor recurrence and lymph node resection. Based on the results of the study, such as LION and SOLO - 1, NCCN ovarian cancer clinical practice guidelines (2019 version 1)" have important update in ovarian cancer surgery way, heat abdominal cavity perfusion chemotherapy and maintenance treatment, most of these progress comes from the RCTs, the evidence whether patients in reality benefit from this, is still limited. In addition, due to the cancer chemotherapy adverse reactions and the complications of patients, antibiotics, NSAIDS, corticosteroids, colony stimulating factors are common taken, in recent years, the auxiliary medicine's influence on the prognosis of malignant tumor has caused the attention of people, their impact for the treatment and prognosis of ovarian cancer and other gynecological malignant tumors is not yet clear. Real-world studies can provide further clinical evidence. There is still a lack of corresponding big data research on the treatment methods of ovarian cancer and uterine body malignant tumor (endometrial cancer and rare uterine body tumor) in China. The establishment of big data platform and platform-based RWS will build the disease database of gynecological malignant tumor in China and get the corresponding RWE to better support clinical diagnosis and treatment. This is a multi-center real world study in China, from January 2002 to December 2022, all medical records of patients diagnosed with gynecological malignant tumor (ovarian malignant tumor or uterine body malignant tumor) by pathology or cytology will be collected, and the data in the actual medical records be analyzed to summarize the characteristics of relevant diseases and diagnosis and treatment, to further evaluate the evolution of the diagnosis and treatment model of gynecological malignancies (ovarian malignancies/uterine malignancies) in China in the real world, as well as the safety and effectiveness of different treatment models in the clinical treatment of patients, to evaluate the influence of auxiliary drugs (eg, aspirin, antibiotics, granulocyte colony stimulating factor (g-csf), glucocorticoids, etc.) for survival, to analysis the risk factors of Chinese gynecology malignant tumor (ovarian malignant tumor or uterine body tumor) and build China gynecology malignant tumor patients' prognosis prediction model, and summarize the rare gynecology malignant tumor (such as ovarian tumor, endometrial sarcoma, clear cell carcinoma, etc.)'s diagnosis and treatment patterns and risk factors, analyze Chinese gynecology malignant tumor (ovarian malignant tumor or uterine body tumor) in patients with gene mutation spectrum, etc. this study is devoted to the provide the real world evidence for the clinical treatment of gynecological malignant tumors in China.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients who has been pathological diagnosed with Gynecological cancers between 2002 and 2022 in China

Description

Inclusion Criteria:

  • pathological diagnosed Gynecological cancers between 2002 and 2022 in China

Exclusion Criteria:

  • diagnosed with other active primary tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Gynecological cancer
patients who has been pathological diagnosed with Gynecological cancers between 2002 and 2022 in China

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Distribution of treatment regimens
Time Frame: 20 years
Proportion of chemotherapy regimens and adjuvant drug (aspirin, antibiotic, antiangiogenic agents, granulocyte colony-stimulating factor[G-CSF], glucocorticoid, etc.) used for the treatment of gynecologic malignant neoplasms.
20 years
overall survival (OS)
Time Frame: 20 years
overall survival, defined as time from first administration of first-line therapy to documented death. To assess clinical effectiveness of any chemotherapy regimens or adjuvant drugs involved in this study by assessment of overall survival (OS) in patients with gynecologic malignant neoplasms. Methods and time intervals for tumor assessment depend on patients' Electronic Medical Record (EHR). Patients will be followed up once a year at least
20 years
Progression free survival (PFS)
Time Frame: 20 years
Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression. To assess clinical effectiveness of any chemotherapy regimens or adjuvant drugs involved in this study by assessment of progression free survival (PFS) in patients with gynecologic malignant neoplasms. Methods and time intervals for tumor assessment depend on patients' Electronic Medical Record (EHR). Patients will be followed up once a year at least.
20 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: 20 years
Progression-free survival, defined as time from first administration of first-line therapy to documented recurrence. To assess clinical effectiveness of any chemotherapy regimens or adjuvant drugs involved in this study by assessment of disease free survival in patients with gynecologic malignant neoplasms. Methods and time intervals for tumor assessment depend on patients' Electronic Medical Record (EHR). Patients will be followed up once a year at least.
20 years
Objective Response Rate (ORR)
Time Frame: 20 years
Objective Response Rate, defined as percentage of patients with complete or partial response according to local assessments. To assess clinical effectiveness of any chemotherapy regimens or adjuvant drugs involved in this study by assessment of objective response rate (ORR) in patients with gynecologic malignant neoplasms. Methods and time intervals for tumor assessment depend on patients' Electronic Medical Record (EHR). Patients will be followed up once a year at least.
20 years
Tumor marker expression level
Time Frame: 20 years
Measurements of tumor biomarkers, such as : CEA, CA-125, CA-199, HE4, ctDNA, etc. Based on patients' Electronic Medical Record (EHR).
20 years
Adverse Event
Time Frame: 20 years
Safety according to CTCAE v4.0 criteria, The incidence of Grade 3 or 4 AE will be accessed according to patients' Electronic Medical Record (EHR).
20 years
Completion Rate of chemotherapy
Time Frame: 20 years
Defined as percentage of patients who has completed their chemotherapy according to schedule. Information will be achieved by patients' Electronic Medical Record (EHR).
20 years
Peritreatment complications
Time Frame: 20 years
defined as complications recorded in patients' Electronic Medical Record (EHR) during the first administration of first-line therapy to the end of anti-cancer treatment.
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-TJ-NVWA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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