NCT06503380 Real-world Study on the Management of Hematological Toxicities Associated With Targeted Therapies for Breast Cancer
| NCT ID | NCT06503380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Hematological Toxicity |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2026-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-07-15 with a primary completion date of 2026-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This multicenter, real-world, observational study will retrospectively and prospectively collect real-world data related to the investigational drugs. We plan to observe 1000 patients and collect data on treatment cycles N and N+1 of the targeted therapies. Retrospective data collection is based on existing patient diagnosis and treatment records, collecting information on patients who have completed two treatment cycles before January 1, 2024. Prospective data collection is based on routine clinical treatment during the study period, collected until the end of the next cycle of treatment or early termination of the study. To observe the disease characteristics and management mode of hematological toxicity related to targeted therapies of breast cancer, and explore the possible related factors of hematological toxicity, such as age, disease subtype, cancer stage, targeted therapy regimens, etc. This study will respect the medication choices of researchers in the study, without specifying which medication to choose for treatment, dosage, mode of administration (including single drug, combination therapy, or sequential therapy), and duration of administration.
Eligibility Criteria
Inclusion Criteria: * · The patients signed the informed consent and voluntarily participated in the study. * A definite diagnosis of any type of breast cancer. * Receiving or has completed targeted therapies. * Investigator judged that the patient need to receive or had received treatment or prevention for CTIT, CIN or CRA induced by targeted therapies. Exclusion Criteria: * · Pregnant or lactating women. * Failure to understand the study or to obtain informed consent. * The investigator determined other situations that are not suitable for inclusion.
Contact & Investigator
Zhi-Ming Shao
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06503380 clinical trial?
This trial is open to participants of all sexes, studying Hematological Toxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06503380 currently recruiting?
Yes, NCT06503380 is actively recruiting participants. Contact the research team at zhi_ming_shao@163.com for enrollment information.
Where is the NCT06503380 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06503380 clinical trial?
NCT06503380 is sponsored by Fudan University. The principal investigator is Zhi-Ming Shao at Fudan University. The trial plans to enroll 1,000 participants.