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

NCT ID: NCT04341480

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 305 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-01-10

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.

Detailed Description

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; previously provisionally named 2019 novel coronavirus or 2019-nCoV) disease (COVID-19) emerged at December 2019 in Wuhan, Hubei Province, China. This infectious disease soon caused a large global outbreak and became a major public health issue. As of 19:00, 12 March 2020, the total number of confirmed cases of SARS-CoV-2 in China has reached 80982 with 3173 death, and 110 other countries have officially reported 45164 cases of SARS-CoV-2 infection with 1520 death.

In this particular time, only patients with SARS-CoV-2 or other diseases with an emergency condition were receipted by most of the hospitals in Hubei Province, even in many other regions of China. The delayed treatment for many chronic diseases, such as malignant tumors, is an increasing serious problem. One major concern was that patients with malignant tumors were generally older in age with low immunity. Preliminary study has shown that cancer patients are most susceptible to infect SARS-CoV-2 and more likely to develop a severe pneumonia. But many other researches suspected that conclusion. Moreover, many of the patients with malignant tumors are facing short term death from tumors rather than the risk of infection. Nevertheless, there is not sufficient evidence to insure the safety of chemotherapy in high-risk region of COVID-19, and there is also not sufficient information to judge which patients' tumor therapy can be appropriately delayed. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Chemotherapy

Intervention Type: DRUG

Routine chemotherapy for individual tumor type.

Control group

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

No interventions assigned to this group

Interventions

Chemotherapy

Routine chemotherapy for individual tumor type.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qinglei Gao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Countries

China

Other Identifiers

2020-TJ-COVID-19

Identifier Type: -

Identifier Source: org_study_id