Clinical 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
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Cancer
Healthy Volunteer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 4000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have diagnosed invasive cancer or healthy volunteers

Brief summary: This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA.

The study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.

Detailed description: AIMA is analysing whole genome sequencing data of circulating tumor DNA, combined through machine learning technique, to develop MCED platform to detect early stage cancer.

The purpose of this prospective, multi-center, observational study is to validate an MCED platform for the early detection of cancers.

The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers.

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)

Primary outcomes:
measure: Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value
timeFrame: 36 months
measure: Accuracy of prediction for the origin of cancer, assessed by concordance rate
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center, Yonsei Univ. College of Medicine
Study officials:
affiliation: Division of Medical Oncology, Yonsei Cancer Center, Yonsei Univ. College of Medicine
name: Joohyuk Sohn
role: PRINCIPAL_INVESTIGATOR
References: