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

NCT07708935 | Recruiting

• 1 other identifier: RWS-DNK2026
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

Young Patients with Malignant Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Young Patients with Malignant Solid Tumors

Young Patients with Malignant Solid Tumors

Other: Ages 18-40

Interventions

Ages 18-40 OTHER

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.

Young Patients with Malignant Solid Tumors

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Young Patients with Malignant Solid Tumors

You may qualify if:

• 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.
• Age and Cohort Definitions:
• 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. Patients will be selected proportionally according to the incidence of each tumor type and propensity score matching principles.
• 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.
• 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.
• Availability of Multimodal Data:
• Relatively complete clinical records must be available, including baseline demographic characteristics, medical records, treatment regimens, and follow-up records.
• 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.

You may not qualify if:

• Uncertain Diagnosis: Patients with an inconclusive histopathological or cytological diagnosis, or without clear documentation of tumor stage according to the TNM staging system.
• 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.
• 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).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Hongxia Wang

CONTACT

021-33988888; whx365@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)