Search / Trial NCT06231953

A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers

Launched by YONSEI UNIVERSITY · Jan 21, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to detect multiple types of cancer early by analyzing DNA found in the blood of cancer patients and healthy volunteers. Researchers aim to develop a testing platform called Multi-Cancer Early Detection (MCED), which could help identify cancer at earlier stages when it is often more treatable. The study will involve around 4,000 participants from various clinical sites in South Korea.

To be eligible for this study, participants must be 19 years old or older and either have been diagnosed with any stage of a solid tumor or be healthy volunteers who are scheduled for a cancer screening. Participants will need to provide blood samples and agree to share their medical information for research purposes. Those who join the study can expect to undergo a simple blood test and will contribute to important research aimed at improving cancer detection. It's important to note that individuals with certain health conditions or recent cancer diagnoses may not qualify for this trial.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • Aged 19 years or older
  • • Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination
  • • Subjects who have agreed to provide clinical information and blood samples
  • • Subjects who have agreed for the storage and secondary use of residual blood samples for research
  • • Subjects who have understood the study and are able to provide a written informed consent
  • Exclusion Criteria:
  • • Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders
  • • Subjects with a history of HIV, HTLV, or Syphilis infection
  • • Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers
  • • Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer)

Trial Officials

Joohyuk Sohn

Principal Investigator

Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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