Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT04820868
Eligibility Criteria:
Inclusion Criteria for All the Participants:
* Ability to provide a written informed consent
* 40-75 years old
* Ability to comply with study procedures
Exclusion Criteria for All the Participants:
* Pregnancy or lactating women
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
Inclusion Criteria for Cancer Arm Participants:
* Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw.
* No prior anti-cancer therapy (local or systematic) prior to study blood draw
Exclusion Criteria for Cancer Arm Participants:
* Known prior or current diagnosis of other types of malignancies or multiple primary tumors
* Diagnosis of benign diseases by histopathological assessments
* No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign
* Non-small-cell lung cancer patients with ground-class nodularity by radiological examination
* Diagnosis of precancerous lesions
Inclusion Criteria for Healthy Arm Participants:
* No cancer-related symptoms or discomfort within 30 days prior to study blood draw
* No clinically significant finding by physical examinations, hematological assessment, urinalysis, LDCT or ultrasound
* No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants
* No active hepatitis B or hepatitis C infection
Exclusion Criteria for Healthy Arm Participants:
* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
* Clinically significant or uncontrolled comorbidities
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT04820868
Study Brief:
Protocol Section:
NCT04820868