An observational study in Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum and Signet Ring Adenocarcinoma of the Colon, sponsored by Fox Chase Cancer Center. Terminated at 1 site in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2018-02-07.
Sponsored by Fox Chase Cancer Center · Observational
This pilot research trial studies telomere length in predicting toxicity in older patients with stage III-IV colorectal cancer undergoing chemotherapy. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and predict how well patients will respond to treatment.
PRIMARY OBJECTIVES:
I. To determine the relationship between pre-treatment telomere length (TL) and rate of grade 3 or higher adverse events occurring on front line leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX)-based chemotherapy among patients over the age of 70 with early stage or metastatic colorectal cancer (CRC).
SECONDARY OBJECTIVES:
I. To evaluate the impact of the FOLFOX-based chemotherapy treatment on peripheral blood lymphocyte telomere length.
II. To evaluate the association between pre-treatment geriatric assessment tools scores, telomere length, and the incidence of chemotherapy related adverse events among older early stage or metastatic CRC patients.
TERTIARY OBJECTIVES:
I. To evaluate the association between pre-treatment levels of serum interleukin-6 (IL-6), C-reactive protein (CRP) and D-dimer and incidence of chemotherapy related adverse events.
II. To evaluate the correlation between pre-treatment telomere length, levels of other biomarkers of aging (IL6, CRP, D-dimer), and rates of adverse events with FOLFOX-based chemotherapy.
OUTLINE:
Patients undergo blood sample collection for analysis via real-time polymerase chain reaction (PCR) at baseline, 3 months, and 6 months.
After completion of study, patients are followed up every 3 months for up to 2 years.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's enrollment of 6 is below the median of 262 across 363 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Fox Chase Cancer Center is the lead sponsor of 215 studies on the registry; 30 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
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Cancer Center
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Exclusion Criteria:
Patients undergo blood collection for analysis via real-time PCR at baseline, 3 months, and 6 months.
Other: cytology specimen collection procedure · Other: laboratory biomarker analysis · Other: questionnaire administration
Undergo blood sample collection
Also known as: cytologic sampling
Correlative studies
Ancillary studies
TL
TL will be compared between participants experiencing at least 1 adverse event and those who experience none using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.
Time frame: Up to 6 months
Incidence of chemotherapy related grade 3 or higher adverse events, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Variance stabilizing and normalizing transformations will be applied to the data when appropriate. Descriptive statistics for participant characteristics, disease presentation, treatment related toxicity, treatment, duration of chemotherapy use, management of adverse events, and frequency of treatment discontinuation will be tabulated. TL will be compared between participants experiencing at least one adverse event and those who do not experience any adverse event using the Mann-Whitney test. A type I error of 5% will be used to determine statistical significance.
Time frame: Up to 6 months
Change in TL after chemotherapy
Variance stabilizing and normalizing transformations will be applied to the data as and when appropriate. TL measured at 3 months and at 6 months after chemotherapy treatment will be compared to baseline (pre-treatment) using the Wilcoxon test or the paired t-test as appropriate. A type I error of 5% will be utilized to determine statistical significance. Pre- and post-treatment TL will be summarized using descriptive statistics.
Time frame: Baseline to 6 months
Association of each geriatric scale, and pro-inflammatory markers to the incidence of chemotherapy related adverse events and TL
Continuous variables will be assessed using the Kruskal-Wallis test or analysis of variance as appropriate and categorical variables will be assessed using Fisher's exact test. Wherever appropriate, Pearson correlation or Spearman's rank correlation will be used to quantify the degree of association between the scales/biomarkers and TL.
Time frame: Up to 6 months
The record gives a start of Oct 2013, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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