Health TrialsbyHealthPanel

Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer

ConditionsLung CancerLung Cancer ScreeningHealthy Volunteers (HV)Unhealthy Volunteers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

The purpose of this research study is to test a new process for diagnosing lung cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future.

Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years old or older

Patient at University of Maryland Baltimore Washington Medical Center

Willing and able to consent to study procedures listed in the protocol

Ability to speak and understand English

Disqualifiers

Younger than 18 years old

Patient not cared for at University of Maryland Baltimore Washington Medical Center

Unable to consent to study procedures listed in the protocol

Unable to speak or understand English

Trial population

Study participants will be selected from patients being cared for at the University of Maryland Baltimore Washington Medical Center

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Epigenetic Signature Assay

    Other intervention

    Up to 15 ml of blood will be collected from each patient at various time points throughout their 5 years of participation. DNA extraction, bisulfite conversion and analysis of epigenetic markers through PCR or next-generation sequencing will be performed. An epigenetic signature assay will then be identified.

Treatment groups

750 Participants
are divided into 5 treatment groups
Group A: Study Population 11 intervention
Group B: Study Population 21 intervention
Group C: Study Population 31 intervention
Group D: Study Population 41 intervention
Group E: Study Population 51 intervention

Trial outcomes

Primary outcomes

1

Identification of tumor-associated host methylation signature

Genome-wide methylation profile of whole blood from lung cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects.

Time frame
5 years
2

Technology development

The investigators will develop array-based assays using whole-blood samples, focused on disease-specific methylation sites to provide early diagnosis, prognosis, and therapeutic efficacy prediction.

Time frame
5 years
3

Technology validation

The investigators will validate identified blood-based circulating methylation signatures in patients with undiagnosed pulmonary nodules.

Time frame
1 year

Secondary outcomes

1

EORTC QLQ-C30 Questionnaire

The European Organization for Research and Treatment of Cancer core quality of life questionnaire, (EORTC QLQ-C30) is a cancer-specific quality of life instrument designed to assess health-related quality of life of cancer patients and is intended to be supplemented by disease-specific questionnaires, such as the lung cancer specific module, the EORTC QLQ-LC13. The EORTC QLQ-C30 incorporates nine multi-item scales including five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea and Financial Difficulties). All of the scales and single-item measures range in score from 0 to 100. A higher score represents a higher level of symptom burden.

Time frame
5 years
2

EORTC QLQ-LC13 Questionnaire

The European Organization for Research and Treatment of Cancer quality of life questionnaire module on Lung Cancer, EORTC QLQ-LC13, is a supplementary questionnaire meant to be used in conjunction with the full QLQ-C30. The QLQ-LC13 incorporates one multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the scales and single-item measures range in score from 0 to 100. A higher score represents a higher level of symptom burden.

Time frame
5 years
3

SF-36v2 Questionnaire

The short-form of 36 questions (SF-36v2) is a multipurpose, 36-item survey that measures eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health. Higher scores indicate better health status.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

EPOCH Epigenetics, Inc

Collaborator

Source ClinicalTrials.gov
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