The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19

NCT04341480 | Unknown

• 1 other identifier: 2020-TJ-COVID-19
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 1

Brief Summary

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. The delayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection, is an increasing serious problem. Here the investigators investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.

Conditions

Gynecological Cancer

Keywords

COVID-19; SARS-CoV-2; Gynecological cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 infection

  Incidence rate of SARS-CoV-2 infection within the whole period of the study.

  through study completion, an average of 3 months.

Secondary Outcomes (3)

• Tumor response

  6 weeks after enrollment.

• Safety and tolerability of chemotherapy as measured by the Common Terminology

  through study completion, an average of 3 months.

• Quality of Life (QOL) measures using Functional Assessment of Cancer Therapy (FACT- ovarian cancer)

  through study completion, an average of 3 months.

Study Arms (2)

Chemotherapy group

Routine chemotherapy every 3 weeks for 2 cycles, and follow up for 2 weeks after discharge from hospital. Total observation duration is 6 weeks.

Drug: Chemotherapy

Control group

No treatment, based on patient's choice. Total observation duration is 6 weeks.

Interventions

Chemotherapy DRUG

Routine chemotherapy for individual tumor type.

Chemotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gynecological malignancy.

You may qualify if:

• Patient is 18 to 80 years old female.
• Patient must have histologically confirmed either type of gynecological malignancies.
• Chemotherapy must be essential for the patient.

You may not qualify if:

• Diagnosed or suspected patients with covid-19 pneumonia, according to the symptom, nucleic acid tests, antibody tests for SARS-CoV-2, or CT scan of the lungs.
• Patient has a prior SARS-CoV-2 infection without clinical cure for 28 days.
• Patient has close contact with diagnosed or suspected SARS-CoV-2 infected person within 14 days.
• Patient has inadequate general condition, severe complication or organ dysfunction not fit for chemotherapy (based on the judgment of researchers).
• Patient or the family refuses to sign the informed consent.
• Patient does not cooperate in following up.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: July 1, 2020
• Primary Completion: December 10, 2022
• Study Completion: January 10, 2023
• Last Updated: October 7, 2021

Record last verified: 2021-10

Locations

CN (1)