A Study of Leukemia Inhibitory Factor Biomarker Monitoring Progression and Treatment Response of Locally-advanced Unresectable and Metastatic Pancreatic Cancer Therapies
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
- Jacksonville, Florida: 22-007253
About this study
The purpose of this study is to determine if LIF (Leukemia Inhibitory Factor) level is positively correlated with disease progression and CA19-9 level in Pancreatic Ductal Adenocarcinoma (PDAC) patients and is a reliable biomarker of response.
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:
- Histologically proven pancreatic ductal adenocarcinoma or adenosquamous carcinoma.
- Any treatment line for palliative systemic therapy for locally advanced unresectable and/or metastatic disease.
- Performance status 0-2.
- Prior neoadjuvant or adjuvant chemotherapy, peri-operative or palliative radiotherapy, and curative or palliative surgical attempts are permitted.
- Medically determined fit patient to receive systemic chemotherapy protocols.
- Adequate marrow (hematologic) and organ function (mainly renal and hepatic) determined by treating physician to participate on the patient preferred treatment strategy.
- Patient with child-bearing potential must discuss effective contraception with treating physician according to discuss potential risk on treatment strategy.
- Interval since baseline laboratory (mainly CA 19-9) and imaging (mainly CT or MRI measurable disease) < 4 weeks from enrollment.
- Patient information and signed informed consent.
- Public or private health insurance coverage.
- Life expectancy greater than 2 months.
- No active concurrent secondary malignancy diagnosis.
- No serious medical or physiological condition precluding participation.
Exclusion Criteria:
- Other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, cyst adenocarcinoma, ampullary carcinoma, lymphoma or other.
- Patient with significant co-morbidities (e.g. heart failure NYHA iii/iv or active coronary syndrome) or active infection (e.g. HIV or chronic hepatitis B or C) or uncontrolled chronic degenerative disease (e.g. diabetes) that may preclude the delivery of treatment determined by treating physician.
- Psychological, familial, sociological or geographical impeding compliance.
- Pregnancy or breast feeding.
Eligibility last updated 7/13/22. Questions regarding updates should be directed to the study team contact.
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 |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Hani Babiker, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available