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

NCT04214964 | Unknown

• 1 other identifier: 2019-TJ-NVWA
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecologic Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer

Keywords

real world study; China

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Disease free survival (DFS)

  20 years

• Objective Response Rate (ORR)

  20 years

• Tumor marker expression level

  20 years

• Adverse Event

  20 years

• Completion Rate of chemotherapy

  20 years

Study Arms (1)

Gynecological cancer

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: this is a study about Gynecological cancers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• pathological diagnosed Gynecological cancers between 2002 and 2022 in China

You may not qualify if:

• diagnosed with other active primary tumors

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (3)

• 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. doi: 10.1056/NEJMsb1609216. No abstract available.

  PMID: 27959688 BACKGROUND

• 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.

  PMID: 29437644 BACKGROUND

• 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.

  PMID: 29232466 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases

Study Officials

• Qinglei Gao, MD, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 2, 2020
• Study Start: April 11, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2024
• Last Updated: October 7, 2021

Record last verified: 2021-10

Locations

CN (1)