DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study (DELFI-L101 Study) (DELFI-L101)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    2500
  • sponsor
    Delfi Diagnostics Inc.
Updated on 19 June 2022
cancer
skin cancer
non-melanoma skin cancer
lung cancer
definitive treatment
lung carcinoma

Summary

The primary objective of this study, DELFI-L101, is to train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features.

Description

Subjects will be enrolled into the DELFI-L101 study after informed consent and eligibility is confirmed. At enrollment, subjects will have blood specimens collected (~40 mL) and 12 months post-enrollment their medical records will be reviewed.

Details
Condition Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Bladder Cancer, Kidney Cancer, Stomach Cancer, Colorectal Cancer, Pancreas Cancer, Liver Cancer
Treatment Blood sample collection
Clinical Study IdentifierNCT04825834
SponsorDelfi Diagnostics Inc.
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All Subjects
Ability to understand and provide written informed consent
Age ≥ 50 years
Current or Former Smoker
≥ 20 pack-years (pack years = number of packs per day X number of years smoked)
Inclusion Group 1: High Risk Patients that meet criteria 5 and 6 below
Prior thoracic imaging (computed tomography (CT)) within 12 months of enrollment OR Planned thoracic imaging (CT) as part of standard of care within 6 weeks of enrollment
AND
Meet one of the criteria below
Inclusion Group 2: High Risk Patients with cancer other than lung cancer that meet the
No suspected or confirmed lung cancer diagnosis OR
Suspected of lung cancer OR
following criteria
Pathologic confirmed, invasive cancer diagnosis, that is not lung cancer with no prior
Confirmed, untreated lung cancer
systemic therapy, definitive therapy, radiation, or surgical resection

Exclusion Criteria

Prior systemic therapy, definitive therapy, radiation, or surgical resection for
cancer within one year prior to enrollment (with the exception of organ biopsies or
surgery for non-melanoma skin cancer)
All Subjects
Any history of hematologic malignancies or myelodysplasia
Any history of organ tissue transplantation
Any history of blood product transfusion
Any condition that in the opinion of the Investigator should preclude the subject's
Current pregnancy
participation in the study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

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