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2010-10
2017-12
2017-12
200
NCT01248637
University Health Network, Toronto
University Health Network, Toronto
OBSERVATIONAL
Study of Intratumoral Hypoxia Using Pre-operative Administration of Pimonidazole
This study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken orally approximately 24 hours before surgical resection of a pancreatic tumor in order to identify areas of lower oxygen content on tumor samples.
Intratumoral hypoxia (low oxygen concentration or pO2) occurs when oxygen consumption exceeds its delivery by the vascular system. Hypoxia is associated with adverse patient outcome in many human cancers and this association is hypothesized to be due to a combination of treatment resistance and aggressive tumor biology. The study of hypoxia is also important as new cancer drugs are being developed that are specifically active on cancer cells in area of tumors with lower oxygen levels. his study involves administering the hypoxia probe pimonidazole hydrochloride to patients prior to resection of pancreatic adenocarcinoma to evaluate the extent, molecular context and clinical relevance of hypoxia in clinical pancreatic cancer samples and the subsequently derived primary xenograft tumors. We propose accrual of patients over a 5-year period to evaluate hypoxia within 100 clinical tumor specimens and corresponding primary xenograft tumours where available. The complementary techniques of wide-field multicolor fluorescence image analysis microscopy and high level flow cytometry will be used to identify potential relationships between intratumoral hypoxia and cell proliferation, differentiation, and the expression of putative cancer stem cell markers.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2010-11-24 | N/A | 2018-07-27 |
2010-11-24 | N/A | 2018-07-30 |
2010-11-25 | N/A | 2018-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Pimonidazole hydrochloride Oral pimonidazole is administered at a dose of 0.5gm/m2 once approximately 24 hrs prior to surgery | DRUG: Pimonidazole hydrochloride
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| characterization of intratumoral hypoxia in pancreatic cancer | estimation of tumoral hypoxic fraction by immunodetection of pimonidazole adducts. | 5 Years |
| correlation of intratumoral hypoxia with patient survival rate | evaluation of correlation of tumoral hypoxia with disease-free survival using Cox proportional hazards analysis | 5 Years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| correlation of hypoxia with molecular markers | colocalization of molecular markers using immunofluorescence microscopy: Stem-cell like populations markers of EMT Endogenous markers of hypoxia (HIF1a, CAIX) | 5 Years |
| to assess utility of circulating osteopontin and miR-210 for identifying hypoxia | correlation of tumoral hypoxic fraction with plasma levels of osteopontin and miR-210 | 5 Years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
