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
Overview
- Phase
- Not Applicable
- Intervention
- No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.
- Conditions
- Cancer
- Sponsor
- Fengming Kong
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- Tumor control, treatment toxicity, quality of life
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Fengming Kong
Tenured Clinical Professor
The University of Hong Kong-Shenzhen Hospital
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •Participants who have supposedly limited ability to complete the survey questionnaires of the present study will be excluded.
Arms & Interventions
Cancer Patients
Those with cancer.
Intervention: No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.
Normal (non cancer) controls
Those without cancer.
Outcomes
Primary Outcomes
Tumor control, treatment toxicity, quality of life
Time Frame: 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.
Changes of treatment-related adverse events as assessed by CTCAE v5.0, and changes of quality of life as assessed by PROMIS-29 Profile v2.1. from baseline, during and after treatment until 2 years after treatment. Tumor response, tumor control, progression-free survival (PFS), cause-specific survival (CSS) and overall survival (OS) evaluated until patients' death or lost to follow-up. Changes of treatment-related adverse events as assessed by CTCAE v5.0, and changes of quality of life as assessed by PROMIS-29 Profile v2.1. from baseline, during and after treatment until 2 years after treatment. Tumor response, tumor control, progression-free survival (PFS), cause-specific survival (CSS) and overall survival (OS) evaluated until patients' death or lost to follow-up.
Secondary Outcomes
- Bio-Imaging-Repository-Databank (BIRD)(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.)