Ovarian Cancer Clinical Trial
Official title:
Clinical Characters of the Diagnosis and Treatment of Gynecological Malignant Tumors in China : A Real World Study
Verified date | October 2021 |
Source | Tongji Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 10000 |
Est. completion date | December 2024 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - pathological diagnosed Gynecological cancers between 2002 and 2022 in China Exclusion Criteria: - diagnosed with other active primary tumors |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
China,
Eisenhauer EA. Real-world evidence in the treatment of ovarian cancer. Ann Oncol. 2017 Nov 1;28(suppl_8):viii61-viii65. doi: 10.1093/annonc/mdx443. Review. — View Citation
Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM. Real-World Evidence - What Is It and What Can It Tell Us? N Engl J Med. 2016 Dec 8;375(23):2293-2297. — View Citation
Sun X, Tan J, Tang L, Guo JJ, Li X. Real world evidence: experience and lessons from China. BMJ. 2018 Feb 5;360:j5262. doi: 10.1136/bmj.j5262. Erratum in: BMJ. 2018 Apr 6;361:k1580. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distribution of treatment regimens | 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 | |
Primary | overall survival (OS) | 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 | |
Primary | Progression free survival (PFS) | 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 | Disease free survival (DFS) | 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 | |
Secondary | Objective Response Rate (ORR) | 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 | |
Secondary | Tumor marker expression level | Measurements of tumor biomarkers, such as : CEA, CA-125, CA-199, HE4, ctDNA, etc. Based on patients' Electronic Medical Record (EHR). | 20 years | |
Secondary | Adverse Event | 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 | |
Secondary | Completion Rate of chemotherapy | 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 | |
Secondary | Peritreatment complications | 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 |
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