Young patients with solid tumors in China: real-world outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, retrospective, real-world study led by Fudan University. Researchers will collect treatment details and multimodal characteristics from medical records of young adults with malignant solid tumors treated in real-world clinical settings. The project analyzes omics data and long-term survival to understand how different treatment approaches relate to organ and fertility preservation and quality of life. It does not intervene in care and relies on decisions made by treating physicians. The goal is to generate evidence to help optimize precision diagnosis and treatment for younger patients with solid tumors in China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Hongxia Wang
• Email: whx365@126.com
• Phone: 021-33988888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.