Tumor Control, Treatment Toxicity, Quality of Life and Bio-Imaging Repository Databank (TQ-BIRD) for Cancer Patients

Официальное название

Tumor Control, Treatment Toxicity, Quality of Life and Bio-Imaging Repository Databank (TQ-BIRD) for Cancer Patients-A Master Protocol for Imaging and Blood Biomarker Group

Обзор

Our central hypothesis is that patient response to treatment, evaluated by full spectrum of outcome measures including tumor control, survival, toxicity, and quality of life (QoL), will correlate with biomarker expressions, which can be tested in the blood, other body fluid, imaging as well as tumor tissue (if available).

Подробное описание

The primary biomarkers of our interest are those obtained from minimally invasive procedures and those associated with immune/inflammatory treatment responses such as lymphocyte count, immune cell subtype distribution, TGF-beta1, immunomodulating interleukins and IDO metabolites. We will measure the biomarkers pre-, during- and post-anticancer treatment for hypothesis driven studies, and bank residual biological specimen, in combination with prospectively collected data including patient/tumor/treatment factors, imaging, tumor control outcome, treatment toxicity and QOL measures. We will classify the tumor response according to RECIST criteria and qualify QoL by using the PROMIS grading system and correlate them with the corresponding biomarkers. This study will serve young investigators who are interested in biomarker studies for early diagnosis, tumor control outcome and treatment toxicity/QOL prediction, aiming to guide personalized cancer care in future.

Вмешательства

• Другое No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.
  Any anticancer or palliative care

Первичные конечные точки

• Tumor control, treatment toxicity, quality of life [Срок оценки: Changes of treatment toxicity and quality of life will be evaluated before, during and after treatment until 2 years after treatment. Treatment efficacy including tumor control will be evaluated until patients' death or lost to follow-up.]

Вторичные конечные точки (1)

• Bio-Imaging-Repository-Databank (BIRD) [Срок оценки: Blood, feces, urine and saliva will be collected, whenever possible before, during and after treatment for at least four times (baseline, middle, at the end and the first follow-up around 1-3 months after treatment.]

Критерии участия

Критерии включения

Cancer Patients

• 18 years of age and older.
• Scheduled to receive any kind of therapy in our center.
• Performance status of ECOG 0, 1, 2, or 3.
• Able to understand QoL questionnaire.

Normal (non cancer) controls

• 18 years of age and older healthy volunteers.
• Without a history of cancer except for cured skin cancer, without any active cancer.
• ECOG Performance status 0, 1, 2, or 3.

Критерии исключения

Participants who have supposedly limited ability to complete the survey questionnaires of the present study will be excluded.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• UHongKongShenzhen — Шэньчжэнь

Публикации

• Zhao CN, Chiang CL, Chiu WK, Chan SK, Li CJ, Chen WW, Zheng DY, Chen WQ, Ji R, Lo CM, Jabbour SK, Chan CA, Kong FS. Treatments of transarterial chemoembolization (TACE), stereotactic body radiotherapy (SBRT) and immunotherapy reshape the systemic tumor immune environment (STIE) in patients with unresectable hepatocellular carcinoma. J Natl Cancer Cent. 2024 Nov 28;5(1):38-49. doi: 10.1016/j.jncc.2 PMID 40040869

Идентификаторы

NCT: NCT05061342 · GCOG0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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