Blood Test Using High-Sensitivity Genetic Analysis for Early Detection and Monitoring of Multiple Cancers

What this Trial Is About

This research aims to validate a highly sensitive and specific blood-based method for the early diagnosis and monitoring of multiple cancers, including ovarian, lung, pancreatic, colorectal, esophageal, breast, kidney, bladder, and gastric cancers. It focuses on improving detection of circulating tumor DNA ctDNA using a newly developed sequencing approach, with a goal to enhance early cancer detection and track minimal residual disease after treatment. Participants include cancer patients undergoing surgery or chemotherapy who will have multiple blood samples taken before treatment, after treatment, and during follow-up visits. Healthy controls or individuals with benign conditions or undergoing routine screenings will provide a single blood sample. Blood samples will be analyzed for circulating tumor DNA, cell-free DNA, RNA, and protein profiles. Tissue biopsies from cancer patients will be examined to compare tumor mutations with those found in blood. Participants will provide blood samples at various times to measure ctDNA variant allele frequency and its relationship to tumor changes and treatment outcomes, including recurrence and survival. The study will use statistical methods to assess diagnostic accuracy and clinical correlations. The total follow-up can extend up to 66 months, with primary outcomes focusing on differences in ctDNA levels between cancer and control groups. This study seeks to develop a non-invasive tool to support earlier detection and better treatment decisions while reducing burdens associated with cancer care.

Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques