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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05061342
Other study ID # GCOG0001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 27, 2019
Est. completion date October 14, 2024

Study information

Verified date September 2021
Source The University of Hong Kong-Shenzhen Hospital
Contact Li YANG, Dr.
Phone 0755-86913333-2107
Email yangl1@hku-szh.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date October 14, 2024
Est. primary completion date June 14, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
China UHongKongShenzhen Shenzhen Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Fengming Kong The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor control, treatment toxicity, quality of life 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.
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.
Secondary Bio-Imaging-Repository-Databank (BIRD) 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. 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.
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