Official Title
The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19, a Prospective Cohort Study
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.

Active, not recruiting
Gynecological Cancer

Drug: Chemotherapy

Routine chemotherapy for individual tumor type.

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.

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
China
Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China

Tongji Hospital
NCT Number
Keywords
Covid-19
SARS-CoV-2
Gynecological cancer
Chemotherapy
MeSH Terms
COVID-19