Gynecological CancerNCT04341480
The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19
An observational study of Gynecological Cancer, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Gynecological Cancer
- What is being tested?
- Chemotherapy
- How many people
- 305 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 10 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gynecological malignancy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19, a Prospective Cohort Study
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.
Read the 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
- Being tested
- Chemotherapy
- Keywords
- COVID-19, SARS-CoV-2, Gynecological cancer, Chemotherapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Routine chemotherapy for individual tumor type.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Chemotherapy | |
| Control group | No treatment, based on patient's choice. Total observation duration is 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 infection
Incidence rate of SARS-CoV-2 infection within the whole period of the study.
Measured: through study completion, an average of 3 months.
Secondary outcomes (3)
Tumor response
Tumor response by determining changes (PD, SD, PR, CR) according to Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1
Measured: 6 weeks after enrollment.
Safety and tolerability of chemotherapy as measured by the Common Terminology
Safety and tolerability of chemotherapy as measured by the Common Terminology Criteria for Adverse Events (version 4.0)
Measured: through study completion, an average of 3 months.
Quality of Life (QOL) measures using Functional Assessment of Cancer Therapy (FACT- ovarian cancer)
To evaluate quality of life (QOL) for the subjects undergoing this treatment, using validated tools. QOL will be assessed every 3 months during treatment course. [Functional Assessment of Cancer Therapy - Ovarian Cancer questionnaire (score range from 0 to 160. Higher scores represent better quality of life.
questionnaire core-30 (QLQ-C30).
Measured: through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Jul 2020
- Primary completion10 Dec 2022 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341480
- Sponsor's protocol ID
- 2020-TJ-COVID-19
- Status last verified
- Oct 2021
- First submitted
- 7 Apr 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Chemotherapy for Patients With Gynecological Malignancy in High-risk Region of COVID-19, a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04341480
- Acronym / sponsor ID
- 2020-TJ-COVID-19
- Conditions
- Gynecological Cancer
- Keywords
- COVID-19, SARS-CoV-2, Gynecological cancer, Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy group | – | Drug: ChemotherapyRoutine chemotherapy every 3 weeks for 2 cycles, and follow up for 2 weeks after discharge from hospital. Total observation duration is 6 weeks. |
| Control group | – | –No treatment, based on patient's choice. Total observation duration is 6 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gynecological malignancy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyRoutine chemotherapy for individual tumor type. | Drug | Chemotherapy group |
Primary outcome
SARS-CoV-2 infection
Time frame: through study completion, an average of 3 months.
Incidence rate of SARS-CoV-2 infection within the whole period of the study.
3 secondary outcomes
Tumor response
Time frame: 6 weeks after enrollment.
Safety and tolerability of chemotherapy as measured by the Common Terminology
Time frame: through study completion, an average of 3 months.
Quality of Life (QOL) measures using Functional Assessment of Cancer Therapy (FACT- ovarian cancer)
Time frame: through study completion, an average of 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecological Cancer, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 infection (time frame: through study completion, an average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.