Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280761
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2006-01-19
Brief Title:
Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
A Biologic Study of Global Gene Expression NF-Kappa B and p53 in Adenocarcinoma of the Rectum
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer It may also help doctors understand how patients respond to treatment
PURPOSE This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy
PURPOSE This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy
Detailed Description:
OBJECTIVES
Primary
Observe whether NF-kappa B is activated in response to treatment with external beam radiotherapy
Correlate NF-kappa B pathway activation presumed to be anti-apoptotic in nature with therapeutic outcomes as measured by rate of pathologic complete response or downstaging by endoscopic ultrasound EUS
Secondary
Study downstream events induced by NF-kappa B activation
Determine global gene expression profiles at baseline and during chemoradiotherapy
Correlate changes in gene expression compared with the baseline gene expression pattern induced by a single dose of external beam radiotherapy with patient outcomes as measured by pathologic response rate or downstaging by EUS
Study downstream events related to activation of p53 in response to treatment with radiotherapy
Correlate p53 pathway-mediated events with clinical outcomes
OUTLINE Patients receive fluorouracil or capecitabine and undergo radiotherapy and surgery per standard care
Patients undergo tumor pinch biopsies at baseline and on days 1 and 2 of chemoradiotherapy At the time of final surgical resection a portion of the remaining rectal tumor will be liquid nitrogen banked Patients not deemed surgical candidates are evaluated by transrectal ultrasound 6-8 weeks after completion of chemoradiotherapy to assess ultrasound response downstaging versus no downstaging
Tumor tissue samples are analyzed for NF-kappa B pathway activation downstream events induced by NF-kappa B activation changes in global gene expression p53 function apoptosis and mRNA expression Laboratory techniques used include tissue microarray ELISA RNase protection assay fluorescence semi-quantitative PCR TUNEL IHC and cDNA microarray analysis
If normal tissue from biopsies is not available whole blood may be collected at any point while patient remains on study for correlative analysis or research related to rectal cancer
Primary
Observe whether NF-kappa B is activated in response to treatment with external beam radiotherapy
Correlate NF-kappa B pathway activation presumed to be anti-apoptotic in nature with therapeutic outcomes as measured by rate of pathologic complete response or downstaging by endoscopic ultrasound EUS
Secondary
Study downstream events induced by NF-kappa B activation
Determine global gene expression profiles at baseline and during chemoradiotherapy
Correlate changes in gene expression compared with the baseline gene expression pattern induced by a single dose of external beam radiotherapy with patient outcomes as measured by pathologic response rate or downstaging by EUS
Study downstream events related to activation of p53 in response to treatment with radiotherapy
Correlate p53 pathway-mediated events with clinical outcomes
OUTLINE Patients receive fluorouracil or capecitabine and undergo radiotherapy and surgery per standard care
Patients undergo tumor pinch biopsies at baseline and on days 1 and 2 of chemoradiotherapy At the time of final surgical resection a portion of the remaining rectal tumor will be liquid nitrogen banked Patients not deemed surgical candidates are evaluated by transrectal ultrasound 6-8 weeks after completion of chemoradiotherapy to assess ultrasound response downstaging versus no downstaging
Tumor tissue samples are analyzed for NF-kappa B pathway activation downstream events induced by NF-kappa B activation changes in global gene expression p53 function apoptosis and mRNA expression Laboratory techniques used include tissue microarray ELISA RNase protection assay fluorescence semi-quantitative PCR TUNEL IHC and cDNA microarray analysis
If normal tissue from biopsies is not available whole blood may be collected at any point while patient remains on study for correlative analysis or research related to rectal cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000561688 | OTHER | PDQ number | httpsreporternihgovquickSearchP30CA016086 |
| P30CA016086 | NIH | None | None |