MyelosuppressionNCT06641934
Current Survey on Chemotherapy-Related Myelosuppression and Clinical Management in Chinese County-level Tumor Patients
An observational study of Myelosuppression, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
Current Survey on Chemotherapy-Related Myelosuppression and Clinical Management in Chinese County-level Tumor Patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myelosuppression
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 20 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese County-level Tumor Patients
Who may be able to join
- The confirmed malignant tumor is one of the non-small cell lung cancer/small cell lung cancer/breast cancer/gastric cancer/esophageal cancer/colorectal cancer/gynecological malignant tumor (ovarian cancer, cervical cancer, endometrial cancer).
- Patients who need to receive chemotherapy in the past 3 months and should continue to receive chemotherapy in the future
- The relevant diagnosis and treatment information involved in the survey is complete: only patients with at least 1-2 examination results after 1 week after chemotherapy can be included
- Understand and sign the informed consent form
- The chemotherapy regimen received for the most recent chemotherapy should be one of the following
- Non-small cell lung cancer TP scheme NP scheme DP scheme EP scheme GP scheme AP scheme Docetaxel/pemetrexed monotherapy Gemcitabine monotherapy Tigio monotherapy ADCs Other monotherapy or combination regimens containing platinum or taxane drugs Drug regimens that combine the above chemotherapy regimens (e.g., immunosuppressants, targeted therapy drugs, etc.)
Show all 12Show fewer
- Small cell lung cancer with etoposide-containing combination regimens Platinum-containing combination regimens (except etoposide) Monotherapy or combination regimen containing topotecan, gemcitabine, paclitaxel Drug regimens that combine the above chemotherapy (e.g., immunosuppressants, targeted therapy drugs, etc.)
- reast cancer ddEC sequential T regimen Anthracyclines and taxanes: TAC, TE, EC-T, ddEC-T, FEC-T regimens Combined taxane protocols: TP, AP, TC, Anthracycline combination regimen: EC, FEC Taxane monotherapy Yew combined with platinum Other platinum-containing regimens: NP, GP ADC drugs Microtubule inhibitors: NVB, taxanes (nab-paclitaxel, paclitaxel liposome, docetaxel), eutidrone, eribulin Microtubule inhibitors in combination with capecitabine Anthracycline monotherapy Drug regimens that combine the above chemotherapy (e.g., targeted therapy drugs, etc.)
- Gastric cancer SOX protocol XELOX scheme FOLFOX protocol DCF scheme ADCs Other monotherapy or combination regimens containing platinum or taxanes or fluorouracil Drug regimens that combine the above chemotherapy (e.g., immunosuppressants, targeted therapy drugs, etc.)
- Esophageal cancer taxane + platinum regimen CF protocol DCF scheme FOLFOX protocol XELOX scheme FLOT scheme FOLFIRI PROTOCOL ECF protocol ECX scheme EOF scheme EOX protocol Other monotherapy or combination regimens containing platinum or taxane or fluorouracil Drug regimens that combine the above chemotherapy (e.g., immunosuppressants, targeted therapy drugs, etc.)
- COLORECTAL CANCER FOLFOXIRI FOLFOX FOLFIRI XELOX Other monotherapy or combination regimens containing platinum or fluorouracil or raltitrexed Drug regimens that combine the above chemotherapy (e.g., immunosuppressants, targeted therapy drugs, etc.)
- Gynecologic malignancies:platinum + taxane or its combination regimen Monotherapy or combination chemotherapy containing docetaxel/gemcitabine/topotecan/irinotecan Regimens (except platinum + taxanes) Other monotherapy or combination chemotherapy regimens containing platinum, taxanes, or anthracyclines
Who cannot join
- Patients with concurrent chemoradiotherapy,
- Patients with sequential chemoradiotherapy, and the irradiation site of radiotherapy is flat bone, sternum, and pelvis;
- Patients with active bleeding before or during treatment; If the patient has received targeted drugs such as CDK4/6 inhibitors or chidaaniline in the front-line treatment, which have a great impact on the blood phase, the drug can be discontinued for at least half a month before it can be included
- Patients who, in the opinion of other physicians, would cause non-chemotherapy-related myelosuppression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 453000
Ji YH yinghua, Dr., 86-0373-4402543, 54234317@qq.com
Ji YH yinghua, Dr., 86-0373-4402452, 1063034720.@qq.com
About this study
Current Survey on Chemotherapy-Related Myelosuppression and Clinical Management in Chinese County-level Tumor Patients
Read the detailed description
The purpose of this research project was to gain an in-depth understanding of the myelosuppression of cancer patients in counties in China after receiving chemotherapy-based treatment regimens through a cross-sectional survey with the help of an online questionnaire system, and to investigate doctors' cognition and treatment concepts of chemotherapy-induced myelosuppression. 1. Fill the gaps in relevant domestic research and provide basic data for follow-up longitudinal studies and intervention studies; 2. Analyze the influencing factors and coping strategies of chemotherapy-induced bone marrow suppression from multiple perspectives, so as to provide reference for improving the knowledge level and treatment level of patients and doctors; 3. Provide more scientific guidance and suggestions for chemotherapy for cancer patients, help patients reduce the harm of bone marrow suppression, improve the survival rate and quality of life of patients, and also provide strong data support for the prevention and treatment of tumors and promote the development of cancer prevention and treatment.
- Conditions
- Myelosuppression
- Being tested
- No intervention; Observational study
- Keywords
- Myelosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; Observational studyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy-Related Myelosuppression | Chemotherapy-Related Myelosuppression Clinical Management Receives: Other: No intervention; Observational study | |
| Chemotherapy-related myelosuppression, primary prevention, treatment rate and clinical management | Chemotherapy-related myelosuppression, primary prevention, treatment rate and clinical management Receives: Other: No intervention; Observational study | |
| Chemotherapy-induced myelosuppression, secondary prevention, treatment rates, and clinical managemen | no intervention Receives: Other: No intervention; Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chemotherapy-related myelosuppression and current status of prophylactic therapy
The incidence and treatment status of chemotherapy-related myelosuppression were investigated in the form of questionnaires Like what：
- Did bone marrow suppression occur after the previous cycle of chemotherapy? (First chemotherapy/occurrence/non-occurrence)
- Did CIM (chemotherapy-induced myelosuppression) occur during this chemotherapy? (Multiple selections allowed)
- Survey questions about existing CIM therapeutic drugs
Measured: 2024.09-2025.09
Secondary outcomes (8)
Incidence of chemotherapy-related myelosuppression
Through questionnaire survey：the incidence of neutropenia during chemotherapy treatment and the rate of primary and secondary prophylaxis;
Measured: 2024.09-2025.09
the rate and economic burden of neutropenia treatment during chemotherapy treatment
Through questionnaire survey：the rate and economic burden of neutropenia treatment during chemotherapy treatment like what:Is there an additional financial burden? A.<500 yuan, B.500-<1000 yuan, C.1000-<3000 yuan, D.≥3000 yuan
Measured: 2024.09-2025.09
the incidence of thrombocytopenia and the rate of primary and secondary prevention and treatment during chemotherapy treatment
Through questionnaire survey： the incidence of thrombocytopenia and the rate of primary and secondary prevention and treatment during chemotherapy treatment like what:Is there primary /secondary prevention in this chemotherapy? Yes/No
Measured: 2024.09-2025.09
thrombocytopenia treatment rate and economic burden during chemotherapy treatment
Through questionnaire survey： thrombocytopenia treatment rate and economic burden during chemotherapy treatment like what：Does it increase the financial burden of patients to a certain extent? Yes/No
Measured: 2024.09-2025.09
the incidence and treatment rate of anemia during chemotherapy treatment;
Through questionnaire survey：the incidence and treatment rate of anemia during chemotherapy treatment like what:Extensive-stage small cell lung cancer/advanced non-small cell lung cancer/advanced HR-negative breast cancer/advanced gastric cancer/advanced esophageal cancer/advanced colorectal cancer/advanced gynaecological malignancy, the overall incidence of CIM in patients with chemotherapy is approximately ()? What is the incidence of grade ≥ 3 ()? A.<10% B. 10%-24% C. 25%-49% D,≥50%
Measured: 2024.09-2025.09
Long and/or short acting granulocyte colony-stimulating factor (G-CSF) and/or Chinese patent medicine usage rate and application scenario cost analysis
Through questionnaire survey：Long and/or short acting granulocyte colony-stimulating factor (G-CSF) and/or Chinese patent medicine usage rate and application scenario cost analysis like what:The number of patients on G-CSF prophylaxis ________ digits/month A. ≤20 B. 21-49 C. 50-99 D. ≥100 What is the proportion of patients with total chemotherapy (including chemotherapy combined with other treatments)________% A. 0%-25% B. 26%-49% C. 50%-75% D. 75%-100% Number of patients with neutropenia afterG-CSF prophylaxis _______ position/month A. ≤20 B. 21-49 C. 50-99 D. ≥100 What percentage of patients are treated with G-CSF prophylaxis________% A. 0%-25% B. 26%-49% C. 50%-75% D. 75%-100%
Measured: 2024.09-2025.09
Recombinant human interleukin-11 and/or thrombopoietin (TPO) and/or thrombopoietin receptor agonists (TPO-RA) and/or cost analysis of application scenarios
Through questionnaire survey：Recombinant human interleukin-11 and/or thrombopoietin (TPO) and/or thrombopoietin receptor agonists (TPO-RA) and/or cost analysis of application scenarios like what:Number of patients receiving chemotherapy (including chemotherapy in combination with other treatments), the number of patients given terbiao/roprostim/other prophylaxis: _______ places/month, A. ≤ 20 B. 21-49 C. 50-99 D. ≥100 What is the proportion of patients with total chemotherapy (including chemotherapy combined with other treatments)________% A. 0%-25% B. 26%-49% C. 50%-75% D. 75%-100% Number of patients with thrombocytopenia after administration of terbiao/roprostim pre/other prophylaxis _______ place/month A. ≤20 B. 21-49 C. 50-99 D. ≥100 What percentage of patients given TPIAO/roprostim prophylaxis ________% A. 0%-25% B. 26%-49% C. 50%-75% D. 75%-100%
Measured: 2024.09-2025.09
Erythropoietin and/or iron and/or Chinese patent medicine usage rate and application scenario cost analysis
Through questionnaire survey：Erythropoietin and/or iron and/or Chinese patent medicine usage rate and application scenario cost analysis like what:What kind of drug treatment to use (multiple choices are allowed)A.Red blood cell transfusion B.Erythropoietin C.Hematopoietic raw materials such as iron supplementation D.Traditional Chinese medicine treatment E.No treatment requiredF. Other: Please describe: ________________
Measured: 2024.09-2025.09
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelosuppressionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Xinxiang Central Hospital of Henan province, Linzhou People Hospital, Inner Huang County Traditional Chinese Hospital, Changyuan People Hospital, Huojia County People Hospital, Huojia County Alliance Hospital, Qinyang People Hospital, Xinan County People Hospital, Henan Hongli Hospital, Army Hospital of the 83rd Army, Anyang Cancer Hospital, Puyang Hospital of Traditional Chinese Medicine, Puyang Huimin Hospital, Hebi People Hospital, The Second People Hospital of Xinxiang Henan
- Responsible party
- Sponsor
- Investigators
- Ji YH yinghua, Dr., Study chair, The First Affiliated Hospital of Xinxiang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641934
- Sponsor's protocol ID
- CHASE009
- Other IDs
- Renco Quick Review No. (19)
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Survey on Chemotherapy-Related Myelosuppression and Clinical Management in Chinese County-level Tumor Patients
- ClinicalTrials.gov ID
- NCT06641934
- Acronym / sponsor ID
- CHASE009
- Conditions
- Myelosuppression
- Keywords
- Myelosuppression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Collaborators
- Xinxiang Central Hospital of Henan province, Linzhou People Hospital, Inner Huang County Traditional Chinese Hospital, Changyuan People Hospital, Huojia County People Hospital, Huojia County Alliance Hospital, Qinyang People Hospital, Xinan County People Hospital, Henan Hongli Hospital, Army Hospital of the 83rd Army, Anyang Cancer Hospital, Puyang Hospital of Traditional Chinese Medicine, Puyang Huimin Hospital, Hebi People Hospital, The Second People Hospital of Xinxiang Henan
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
Current Survey on Chemotherapy-Related Myelosuppression and Clinical Management in Chinese County-level Tumor Patients
Detailed description
The purpose of this research project was to gain an in-depth understanding of the myelosuppression of cancer patients in counties in China after receiving chemotherapy-based treatment regimens through a cross-sectional survey with the help of an online questionnaire system, and to investigate doctors' cognition and treatment concepts of chemotherapy-induced myelosuppression. 1. Fill the gaps in relevant domestic research and provide basic data for follow-up longitudinal studies and intervention studies; 2. Analyze the influencing factors and coping strategies of chemotherapy-induced bone marrow suppression from multiple perspectives, so as to provide reference for improving the knowledge level and treatment level of patients and doctors; 3. Provide more scientific guidance and suggestions for chemotherapy for cancer patients, help patients reduce the harm of bone marrow suppression, improve the survival rate and quality of life of patients, and also provide strong data support for the prevention and treatment of tumors and promote the development of cancer prevention and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy-Related Myelosuppression | – | Other: No intervention; Observational studyChemotherapy-Related Myelosuppression Clinical Management |
| Chemotherapy-related myelosuppression, primary prevention, treatment rate and clinical management | – | Other: No intervention; Observational studyChemotherapy-related myelosuppression, primary prevention, treatment rate and clinical management |
| Chemotherapy-induced myelosuppression, secondary prevention, treatment rates, and clinical managemen | – | Other: No intervention; Observational studyno intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese County-level Tumor Patients
Key inclusion criteria (12 listed)
- The confirmed malignant tumor is one of the non-small cell lung cancer/small cell lung cancer/breast cancer/gastric cancer/esophageal cancer/colorectal cancer/gynecological malignant tumor (ovarian cancer, cervical cancer, endometrial cancer).
- Patients who need to receive chemotherapy in the past 3 months and should continue to receive chemotherapy in the future
- The relevant diagnosis and treatment information involved in the survey is complete: only patients with at least 1-2 examination results after 1 week after chemotherapy can be included
- Understand and sign the informed consent form
- The chemotherapy regimen received for the most recent chemotherapy should be one of the following
Key exclusion criteria (4 listed)
- Patients with concurrent chemoradiotherapy,
- Patients with sequential chemoradiotherapy, and the irradiation site of radiotherapy is flat bone, sternum, and pelvis;
- Patients with active bleeding before or during treatment; If the patient has received targeted drugs such as CDK4/6 inhibitors or chidaaniline in the front-line treatment, which have a great impact on the blood phase, the drug can be discontinued for at least half a month before it can be included
- Patients who, in the opinion of other physicians, would cause non-chemotherapy-related myelosuppression
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 |
|---|---|---|
| No intervention; Observational studyNo intervention | Other | Chemotherapy-Related Myelosuppression, Chemotherapy-induced myelosuppression, secondary prevention, treatment rates, and clinical managemen, Chemotherapy-related myelosuppression, primary prevention, treatment rate and clinical management |
Primary outcome
Incidence of chemotherapy-related myelosuppression and current status of prophylactic therapy
Time frame: 2024.09-2025.09
The incidence and treatment status of chemotherapy-related myelosuppression were investigated in the form of questionnaires Like what： 1. Did bone marrow suppression occur after the previous cycle of chemotherapy? (First chemotherapy/occurrence/non-occurrence) 2. Did CIM (chemotherapy-induced myelosuppression) occur during this chemotherapy? (Multiple selections allowed) 3. Survey questions about existing CIM therapeutic drugs
8 secondary outcomes
Incidence of chemotherapy-related myelosuppression
Time frame: 2024.09-2025.09
the rate and economic burden of neutropenia treatment during chemotherapy treatment
Time frame: 2024.09-2025.09
the incidence of thrombocytopenia and the rate of primary and secondary prevention and treatment during chemotherapy treatment
Time frame: 2024.09-2025.09
thrombocytopenia treatment rate and economic burden during chemotherapy treatment
Time frame: 2024.09-2025.09
the incidence and treatment rate of anemia during chemotherapy treatment;
Time frame: 2024.09-2025.09
Long and/or short acting granulocyte colony-stimulating factor (G-CSF) and/or Chinese patent medicine usage rate and application scenario cost analysis
Time frame: 2024.09-2025.09
Recombinant human interleukin-11 and/or thrombopoietin (TPO) and/or thrombopoietin receptor agonists (TPO-RA) and/or cost analysis of application scenarios
Time frame: 2024.09-2025.09
Erythropoietin and/or iron and/or Chinese patent medicine usage rate and application scenario cost analysis
Time frame: 2024.09-2025.09
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Tumor Patients
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.
Ji YH yinghua, Dr. study chair
The First Affiliated Hospital of Xinxiang Medical College
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 Myelosuppression, run by The First Affiliated Hospital of Xinxiang Medical College 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 12 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JI YH yinghua, Dr. (86-0373-13663030446, 54234317@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chemotherapy-related myelosuppression and current status of prophylactic therapy (time frame: 2024.09-2025.09). 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 16 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.