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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Assessment of Special Needs and Quality of Life (QoL) [Срок оценки: January 1, 2010 to December 31, 2027]

Критерии участия

Критерии включения

• 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:

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.

• 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:

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.

Критерии исключения

• 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).
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07708935 · RWS-DNK2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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