Cancer
Conditions
Keywords
surgery, systemic therapy, radiotherapy, biomarker, imaging, toxicity, quality of life
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.
Interventions
OTHERNo experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.
Any anticancer or palliative care
Sponsors
Fengming Kong
Queen Mary Hospital, Hong Kong
Taizhou Hospital
Peking University Shenzhen Hospital
Shenzhen People's Hospital
The First Affiliated Hospital of Henan Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 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.
Exclusion criteria
Participants who have supposedly limited ability to complete the survey questionnaires of the present study will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor control, treatment toxicity, quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Prospectively collect and store body fluids samples from cancer patients treated with various anticancer treatments, including palliative care to establish a bio-Imaging-repository-databank covering an extensive repository and prospective clinically relevant data. |
Countries
China
Contacts
CONTACTLi YANG, Dr.
PRINCIPAL_INVESTIGATORFeng-Ming (Spring) KONG, Professor
The University of Hong Kong-Shenzhen Hospital
Outcome results
None listed