A blood test to determine the probability of developing cancer and/ or its stage, by analysing the expression profile of molecular immuno-markers in healthy and cancer patients (with histologically or cytologically proven malignancy-solid tumors or haematological malignancy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The expression profile of the molecular immuno-
研究概览
简要总结
Tumor markers are substances, often proteins, that are produced by the cancer tissue itself or sometimes by the body in response to cancer growth. Because some of these substances can be detected in body samples such as blood, urine, and tissue, these markers may be used, along with other tests and procedures, to help detect and diagnose some types of cancer, predict and monitor a person’s response to certain treatments, and detect recurrence. Novel tests have been developed that look for changes in genetic material (DNA, RNA), rather than proteins, in cancer patient samples. The genetic changes have been found to be associated with certain cancers and can be used as tumor markers to help determine prognosis, guide targeted treatment, and/or detect cancers early on. Moreover, advances in technology have led to tests that can evaluate several genetic markers or panels of markers at the same time, providing expanded information about the characteristics of a tumor.
This study is conducted to determine the probability of developing cancer and/ or its stage, by analyzing the expression profile of molecular immuno-markers in the peripheral blood sample of healthy and cancer patients
Study Objectives:
Primary:
- To evaluate the expression profile of Molecular Immuno-markers in the peripheral
blood of healthy and cancer patients
- To evaluate Circulating tumor DNA in the peripheral blood of healthy and cancer
patients
Secondary :
To follow up with pre-cancer/ high-risk individuals and selected cancer individuals with
telephonic visits every 3 monthly and conduct blood test at regular intervals.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Have any type of histologically or cytologically proven (solid tumors or haematological ) cancer which will assist in meeting the Primary objective of this study (Cancer group) (OR) ï‚· Individuals who are NOT a known case of any malignancy( Non-Cancer group) ï‚· Are aged 18 years or older.
- •ï‚· Are willing to consent to storage of specimens for future research.
- •ï‚· Are willing to comply with study procedures and follow-ups ï‚· Subjects enrolled will be able to provide informed consent for themselves.
排除标准
- •Are incarcerated.
- •ï‚· Are unwilling or unable to comply with prescribed therapy.
- •ï‚· Subjects that lack the capacity to provide informed consent autonomously are to be excluded.
- •ï‚· Pregnant or lactating women.
- •ï‚· Subjects who have participated in any clinical trial in the past 1 month.
- •ï‚· Any subjects found to have entered into the study in violation of this protocol or if the subject is uncooperative during the study ï‚· Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
结局指标
主要结局
The expression profile of the molecular immuno-
时间窗: 30 days
markers will help in analysing the probability of manifestation of cancer, before any clinical
时间窗: 30 days
symptoms begin to appear in healthy individuals.
时间窗: 30 days
The expression profile of the molecular immuno-markers in cancer patients will help in determining the efficacy of the ongoing
时间窗: 30 days
treatment and for cancer survivors it will aid in determining the risk of relapse of the disease.
时间窗: 30 days
次要结局
- To follow up with pre-cancer/ high-risk individuals and selected cancer individuals with(telephonic visits every 3 months and conduct blood test at every six months)