Cancer Clinical Trial
— DACOSOfficial title:
A Multi-Center Prospective Cohort Study of Dampness Syndrome in China
NCT number | NCT05315895 |
Other study ID # | SZ2021ZZ06 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 6, 2022 |
Est. completion date | March 30, 2028 |
The researchers plain to build a large-scale, longitudinal, prospective cohort characterized by TCM dampness syndrome. With the biobank of this cohort the investigators want to find the causality between TCM dampness syndrome and clinical chronic diseases and a new way to treat clinical disease.
Status | Recruiting |
Enrollment | 100000 |
Est. completion date | March 30, 2028 |
Est. primary completion date | December 30, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years to 79 Years |
Eligibility | Inclusion Criteria: 1. Residents aged 30 to 79, whose residence is consistent with their registered permanent residence location; 2. Residents who voluntarily participate in the project, agree to the collection of their biological information, and sign the informed consent form; 3. Residents who have no mental illness and other related diseases, and display a normal ability of expression and understanding; Exclusion Criteria: 1. Residents who reject collaboration; 2. Residents who allow no follow-up visits. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Province Hospital of Tradtional Chinese Medicine | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangzhou University of Traditional Chinese Medicine | State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | emerging diseases | This study will pay attention to the emerging situation of clinical chronic diseases, such as cancer, diabetes, hypertension, coronary heart disease, dementia, etc. Each follow-up the researchers will record the incidence of the emerging diseases of interviewees' by questionnaire including the name of the disease, time of onset and treatments. | through study completion, an average of 1 year | |
Secondary | Montreal Cognitive Assessment(MoCA) | MoCA is a brief, 30-question test that helps healthcare professionals detect cognitive impairments very early on, allowing for faster diagnosis and patient care. MoCA is the most sensitive test available for detecting Alzheimer's disease, measuring executive functions and multiple cognitive domains. The value range 0-30: higher scores mean a better Cognitine. The score above 26 is considered the normal congnitive level | through study completion, an average of 1 year | |
Secondary | European Quality of Life 5-dimensional questionnaire (EQ-5D-5L) | The EQ-5D comprises five dimensions of health: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. . EQ-5D-5L, includes five levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). The value range 0-100: higher scores mean a worse outcome. | through study completion, an average of 1 year | |
Secondary | Mini-Mental State Exam (MMSE) | MMSE is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The value range 0-30: higher scores mean a better Cognitine. | through study completion, an average of 1 year | |
Secondary | interview questionnaire | Demographic characteristic, life style. disease history, allergies will be involoved. | through study completion, an average of 1 year | |
Secondary | change of the blood routine results | WBC, RBC, PLT , HB, NEUT% and LYM% will be tested and recorded. Above or below each mormal value will be considered as abnormal. | through study completion, an average of 1 year | |
Secondary | urine routine | urinary WBC and urinary RBC will be observed. negative or below 5/HP is normal.
BLO and GLU and PRO in urine will also be test. Negative is normal. |
through study completion, an average of 1 year | |
Secondary | change of faeces routine | cells in faeces will be tested such as RBC and WBC. Negative occult blood(FOB) is difined normal. | through study completion, an average of 1 year | |
Secondary | change of hepatic function | The researchers will check the results of ALT and AST. TBil, DBIL, TBA and TP, ALB. Any indices above or below the criteria range is defined as abnormal. Every time point investigators will record the change of these indices. | an average of 1 year | |
Secondary | change of renal function | The researchers will check the results of Cr, BUN, TC, LDL, HDL,UA and fasting blood glucose,glycosylanted. Any indices above or below the criteria range is defined as abnormal. Every time point investigators will record the change of these indices. | an average of 1 year | |
Secondary | change of CRP | change of CPP | an average of 1 year | |
Secondary | change of Hcy | change of Hcy | an average of 1 year | |
Secondary | change of thyroid function | change of TSH ,FT3, FT4 | an average of 1 year | |
Secondary | change of Vit B12 and folic acid | change of Vit B12 | an average of 1 year | |
Secondary | change of coagulation function | change of PT, INR,TT,APTT,FIB | an average of 1 year | |
Secondary | change of abdominal ultrasound | change of abdominal ultrasound | an average of 1 year | |
Secondary | change of gynecologic ultrasound | change of gynecologic ultrasound | an average of 1 year | |
Secondary | change of ECG | The researchers will check the change of P, QRS and ST segments separately in electrocardiogram. | an average of 1 year | |
Secondary | change of brain MRI | change of brain MRI. The investigators will focus on the change of hippocampal volume and the spacing of temporal sulcus gyrus. | an average of 1 year |
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