A Study to Assess DNA Tumor Markers in Whole Blood Specimens of Patients with Newly Diagnosed Lung Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-000269
Sponsor Protocol Number: 16-000269
About this study
The purpose of this study is to assess Methylated DNA tumor markers distributed in blood samples of patients newly diagnosed with different types of lung cancer. The goal is to develop new blood screening tests that can identify the type and primary site of cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- From Lung Archive - IBB # 442-99
- Cancer cases, n=100 (adeno 50, squamous 40, other 10)
- Disease controls (benign lung nodules), n=50
- From Prospective Case Cohort
- Cancer cases, n=150 (distribution roughly same as for archival cases)
- From Parallel Control Study, n=2000 - IRB #15-006191
- Controls matched on age, sex, and smoking history will be selected from this larger parallel study (at least 300 independent controls for each case group).
- For exploratory Disease Control group (Aim 4), 4 ml (minimum of 2 ml) plasma will be requested for each of following tumor subsets:
- Lymphoma, n=20 (any stage or site, at least 10 non-Hodgkins)
- Obtained from Dr. Thomas Witzig’s Lymphoma SPORE registry (IRB # 118-01)
- Thyroid, n=20 (any stage, at least half non-papillary)
- Obtained prospectively from Oncology calendars
- Breast, n=20 (stage (half I-II, half III-IV), ER status (half positive, half negative)
- Obtained from Dr. Fergus Couch and Janet Olson’s Breast Cancer Registry (IRB # 1815-04)
- Prostate, n=20 (half Gleason’s 6 or less, half Gleason’s 7 or higher)
- Obtained from Dr. Matthew Gettman’s Prostate protocol (IRB # 15-009309)
- Gynecologic, n=20 (Ovarian, n=10 (any stage or type); Uterine, n=10 (any stage or type))
- Ovarian obtained from Dr. Kimberly Kalli’s Ovarian Cancer registry (IRB#08-005749)
- Uterine obtained from Dr. Sean Dowdy’s Endometrial cancer bank (IRB # 2405-04)
- Kidney, n=20 (any stage or type)
- Obtained from Dr. R. Houston Thompson’s (IRB # 14-03)
- Esophagus, n=20 (any stage, type (10 adeno, 10 squamous cell))
- Obtained from Dr. Navtej Buttar’s Esophageal Biospecimen Registry (IRB #495-01)
- Stomach, n=20 (any stage or type)
- Obtained from Dr. Lisa Boardman’s GI Tumor Registry (IRB # 622-00)
- Liver, n=20 (any stage)
- Obtained from Dr. Lewis Roberts’ Liver Registry (RB # 707-03)
- Pancreas, n=20 (any stage)
- Obtained from Dr. David Ahlquist’s Compartmentalization study (IRB # 15-001127)
- Colorectum, n=20 (stage (half I-II, half III-IV)
- Obtained from Dr. Lisa Boardman’s GI Tumor Registry (IRB # 622-00) or Dr. David Ahlquist’s Compartmentalization study (IRB # 15-001127)
Exclusion Criteria:
- Known primary cancer outside of the lungs within the last 5 years (not including basal cell or squamous cell skin cancers) (primary aim only)
- Current target pathology is a recurrence
- Prior or active chemotherapy or radiation for the primary lung cancer (primary aim only)
- Patient has had a transplant
- Inability to give informed consent (prospective groups only)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Kisiel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available