NCT07708935 Real-World Study of Young Patients With Solid Tumors in China
| NCT ID | NCT07708935 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 12,000 participants |
| Start Date | 2026-07-31 |
| Primary Completion | 2027-07-31 |
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 12,000 participants in total. It began in 2026-07-31 with a primary completion date of 2027-07-31.
⚠ 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
To evaluate organ preservation rates, fertility preservation, and long-term quality of life after treatment among young patients.
Eligibility Criteria
Inclusion Criteria: 1. Confirmed Diagnosis: Patients with malignant solid tumors confirmed by histopathological or cytological examination. The primary tumor types of interest include, but are not limited to, breast cancer, malignant melanoma, and multiple primary tumors. 2. Age and Cohort Definitions: 2.1. Young Cohort (Core Population): Patients aged ≤40 years at the time of initial diagnosis of a malignant tumor. 2.2. Older Control Cohort: Patients aged \>40 years at the time of initial diagnosis of a malignant tumor. Patients will be selected proportionally according to the incidence of each tumor type and propensity score matching principles. 3. Eligible Time Window: The initial diagnosis or receipt of antitumor treatment at the participating center must have occurred between January 1, 2010, and May 31, 2026. 4. Treatment History: Patients must have received at least one standard antitumor treatment at a participating study center, including but not limited to curative or palliative surgery, neoadjuvant or adjuvant systemic therapy, and first-line or later-line chemotherapy, targeted therapy, or immunotherapy for advanced disease. 5. Availability of Multimodal Data: 5.1. Relatively complete clinical records must be available, including baseline demographic characteristics, medical records, treatment regimens, and follow-up records. 5.2. Baseline imaging data must be available, such as CT, MRI, or PET-CT scans. 5.3. Pathological tissue samples, such as formalin-fixed, paraffin-embedded (FFPE) blocks or unstained slides, must be available to support subsequent digital pathology and radiomic feature extraction. Exclusion Criteria: 1. Uncertain Diagnosis: Patients with an inconclusive histopathological or cytological diagnosis, or without clear documentation of tumor stage according to the TNM staging system. 2. Severe Missingness of Core Data: Patients with substantially incomplete clinical records, such as missing documentation of key treatment regimens, absence of any baseline imaging assessment, or no follow-up records whatsoever due to loss to follow-up. 3. Potential Confounding From Multiple Primary Malignancies: Patients with a concurrent malignancy or a history of another malignancy within the previous 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma, to avoid confounding the analysis of survival outcomes, including overall survival (OS) and progression-free survival (PFS). 4. Deemed Unsuitable by the Investigator: Patients considered by the investigator, based on clinical judgment, to have other conditions that make them unsuitable for inclusion in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07708935 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07708935 currently recruiting?
Yes, NCT07708935 is actively recruiting participants. Contact the research team at whx365@126.com for enrollment information.
Where is the NCT07708935 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07708935 clinical trial?
NCT07708935 is sponsored by Fudan University. The trial plans to enroll 12,000 participants.
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