Real-World Study of Young Patients With Solid Tumors in China

A Multicenter Real-World Study on the Diagnosis, Treatment, and Long-Term Survival of Young Patients With Malignant Solid Tumors in China

To evaluate organ preservation rates, fertility preservation, and long-term quality of life after treatment among young patients.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Ages 18-40

Detailed Description

This is a multicenter, retrospective, real-world study. The study will systematically collect data on treatment strategies and multimodal characteristics of young patients with malignant solid tumors in China who receive care in real-world clinical settings.

This is a non-interventional study conducted entirely on the basis of routine clinical decisions made by treating physicians, without interfering with any aspect of the patients' treatment. By analyzing the characteristics, multimodal omics data, and long-term survival outcomes of young patients receiving different treatment strategies, this study aims to provide real-world evidence to support the optimization of precision diagnosis and treatment for malignant tumors in young patients.

• Study Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Hongxia Wang; Phone Number: 021-33988888; Email: whx365@126.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Juan Jin, PhD; Phone Number: 021-33988888; Email: medjinjuan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Young Patients with Malignant Solid Tumors

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Young Patients with Malignant Solid Tumors	Other: Ages 18-40; Young Cohort (Core Population): Patients aged ≤40 years at the time of initial diagnosis of a malignant tumor. Older Control Cohort: Patients aged >40 years at the time of initial diagnosis of a malignant tumor, selected proportionally according to the incidence of each tumor type and propensity score matching principles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Special Needs and Quality of Life (QoL)	To evaluate organ preservation rates during treatment among young patients, including breast-conserving surgery, sphincter-preserving surgery, and limb-sparing surgery; fertility preservation; long-term quality of life after treatment; and the proportion of patients who return to society and/or work.	January 1, 2010 to December 31, 2027

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Young Patients with Malignant Solid Tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: RWS-DNK2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No