Page last updated: 2024-10-20
spermine and Cancer, Second Primary
spermine has been researched along with Cancer, Second Primary in 1 studies
Research
Studies (1)
Timeframe | Studies, this research(%) | All Research% |
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 1 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors
Authors | Studies |
Thompson, PA | 1 |
Wertheim, BC | 1 |
Zell, JA | 1 |
Chen, WP | 1 |
McLaren, CE | 1 |
LaFleur, BJ | 1 |
Meyskens, FL | 1 |
Gerner, EW | 1 |
Clinical Trials (1)
Trial Overview
Trial | Phase | Enrollment | Study Type | Start Date | Status |
A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon[NCT00118365] | Phase 3 | 375 participants (Actual) | Interventional | 1998-07-31 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Adverse Events With a Grade of 3 and Above
"Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other.~Per protocol, not all grade 3 events are considered as serious events." (NCT00118365)
Timeframe: Up to 36 months
Intervention | participants (Number) |
---|
Arm I (Eflornithine and Sulindac) | 46 |
Arm II (Placebo) | 37 |
Baseline Putrescine by ODC Genotype
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete. (NCT00118365)
Timeframe: Baseline
Intervention | nmol/mg protein (Median) |
---|
ODC1 AA/GA | 0.47 |
ODC1 GG | 0.56 |
Baseline Spermidine by ODC Genotype
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete. (NCT00118365)
Timeframe: Baseline
Intervention | nmol/mg protein (Median) |
---|
ODC1 AA/GA | 1.99 |
ODC1 GG | 2.17 |
Baseline Spermine by ODC Genotype
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete. (NCT00118365)
Timeframe: Baseline
Intervention | nmol/mg protein (Median) |
---|
ODC1 AA/GA | 6.82 |
ODC1 GG | 7.29 |
Biomarker in Adenoma - Ki-67
Estimated mean percent of cells staining postivie for the Ki-67 based on the GEE approach with adjustment for covariates (NCT00118365)
Timeframe: At the end of the study
Intervention | percentage of cells that are positive (Mean) |
---|
Arm I (Eflornithine and Sulindac) | 59.5 |
Arm II (Placebo) | 63.9 |
Biomarker in Adenoma - p53
"Estimated mean percent of cells staining postivie for p53 based on GEE approach with adjument for covariates.~Tumor protein p53, also known as p53, cellular tumor antigen p53, phosphoprotein p53, or tumor suppressor p53, is a protein that in humans is encoded by the TP53 gene." (NCT00118365)
Timeframe: At the end of the study
Intervention | percentage of cells that are positive (Mean) |
---|
Arm I (Eflornithine and Sulindac) | 75.6 |
Arm II (Placebo) | 70.3 |
Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group
ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete. (NCT00118365)
Timeframe: Up to 36 months
Intervention | participants (Number) |
---|
DFMO + Sulindac - GG | 7 |
DFMO + Sulindac - AA/GA | 9 |
Placebo - GG | 22 |
Placebo - AA/GA | 18 |
At the End of the Study - Putrescine Response by ODC Genotype
"Putrescine responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) ≥ the threshold. Putrescine non-responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete." (NCT00118365)
Timeframe: At the end of the study
Intervention | participants (Number) |
---|
| Responder | Non-Responder |
---|
DFMO + Sulindac - AA/GA | 21 | 19 |
,DFMO + Sulindac - GG | 26 | 32 |
,Placebo - AA/GA | 12 | 37 |
,Placebo - GG | 12 | 31 |
At the End of the Study - Spermidine Response by ODC Genotype
"Spermidine responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) ≥ the threshold. Spermidine non-responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete." (NCT00118365)
Timeframe: At the end of the study
Intervention | participants (Number) |
---|
| Responder | Non-Responder |
---|
DFMO + Sulindac - AA/GA | 12 | 28 |
,DFMO + Sulindac - GG | 25 | 32 |
,Placebo - AA/GA | 11 | 38 |
,Placebo - GG | 15 | 28 |
At the End of the Study - Spermine Response by ODC Genotype
"Spermine responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) ≥ the threshold. Spermine non-responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30.~ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete." (NCT00118365)
Timeframe: At the end of the study
Intervention | participants (Number) |
---|
| Responder | Non-Responder |
---|
DFMO + Sulindac - AA/GA | 7 | 33 |
,DFMO + Sulindac - GG | 7 | 51 |
,Placebo - AA/GA | 10 | 39 |
,Placebo - GG | 18 | 25 |
Biomarker in Adenoma: Apoptosis
Apoptosis expression was assessed using cytoplasmic staining. The definitions for the category level for the Apoptosis are: 1. focal (less than 10% cells that are positively stained); 2. less than 50% cells are positively stained; 3. more than 50% cells are positively stained. (NCT00118365)
Timeframe: At the end of the study
Intervention | adenoma (Number) |
---|
| A pattern equal to normal mucosa | 1.focal (<10%) | 2.cyto less than 50% | 3.cyto more than 50% |
---|
Arm I (Eflornithine and Sulindac) | 2 | 7 | 1 | 2 |
,Arm II (Placebo) | 4 | 20 | 23 | 13 |
Biomarker in Adenoma: Bcl-2
bcl-2 is the anti-apoptotic protein BCL2 (NCT00118365)
Timeframe: At the end of the study, up to 3 years
Intervention | Adenoma (Number) |
---|
| A pattern equal to normal mucosa | 1.<10% of the cells in the adenoma showed staining | 2.10-50% cells showed staining | 3.>50% cells showed staining | Insufficient tissue |
---|
Arm I (Eflornithine and Sulindac) | 4 | 4 | 3 | 1 | 0 |
,Arm II (Placebo) | 17 | 25 | 14 | 8 | 2 |
Biomarker in Adenoma: CEA
carcino-embryonic antigen (CEA) is adenocarcinoma tissue marker that is expressed during adenoma formation. (NCT00118365)
Timeframe: At the end of the study
Intervention | Adenoma (Number) |
---|
| A pattern equal to normal mucosa | 1.<50% of cells showed staining | 2.50-90% of cells showed staining | 3.>90% of cells showed staining | Insufficient tissue |
---|
Arm I (Eflornithine and Sulindac) | 1 | 5 | 6 | 0 | 0 |
,Arm II (Placebo) | 5 | 15 | 35 | 9 | 2 |
Biomarker in Adenoma: Sialyl-TN (B72.3)
sialyl-Tn (B72.3) is adenocarcinoma tissue marker that is expressed during adenoma formation. (NCT00118365)
Timeframe: At the end of the study
Intervention | Adenoma (Number) |
---|
| a pattern equal to normal mucosa | 1.<10% of the cells in the adenoma showed staining | 2.10-50% cells showed staining | 3.>50% cells showed staining | Insufficient tissue |
---|
Arm I (Eflornithine and Sulindac) | 3 | 7 | 2 | 0 | 0 |
,Arm II (Placebo) | 11 | 32 | 17 | 5 | 1 |
Detection of Any Adenoma at the End of the Study
Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done. (NCT00118365)
Timeframe: Up to 36 months
Intervention | participants (Number) |
---|
| Yes | No |
---|
Arm I (Eflornithine and Sulindac) | 17 | 121 |
,Arm II (Placebo) | 53 | 76 |
Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment
This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort. (NCT00118365)
Timeframe: Up to 36 months
Intervention | participants (Number) |
---|
| Yes | No |
---|
Eflornithine and Sulindac + High PGE2 at Baseline | 3 | 41 |
,Eflornithine and Sulindac + Low PGE2 at Baseline | 12 | 41 |
,Placebo + High PGE2 at Baseline | 21 | 32 |
,Placebo + Low PGE2 at Baseline | 19 | 23 |
Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment
The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort. (NCT00118365)
Timeframe: Up 36 months
Intervention | participants (Number) |
---|
| Yes | No |
---|
Eflornithine and Sulindac + High Putrescine at Baseline | 10 | 56 |
,Eflornithine and Sulindac + Low Putrescine at Baseline | 7 | 63 |
,Placebo + High Putrescine at Baseline | 31 | 36 |
,Placebo + Low Putrescine at Baseline | 24 | 38 |
Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment
"The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort.~In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset.~The analysis cohort is based on the participants whose data are available and complete." (NCT00118365)
Timeframe: Up 36 months
Intervention | participants (Number) |
---|
| Yes | No |
---|
Eflornithine and Sulindac + High Spd:Spm at Baseline | 12 | 60 |
,Eflornithine and Sulindac + Low Spd:Spm at Baseline | 5 | 59 |
,Placebo + High Spd:Spm at Baseline | 24 | 37 |
,Placebo + Low Spd:Spm at Baseline | 31 | 37 |
Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment
PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete. (NCT00118365)
Timeframe: Up to 36 months
Intervention | participants (Number) |
---|
| Yes | No |
---|
Eflornithine and Sulindac + PGE2 Nonresponders | 8 | 27 |
,Eflornithine and Sulindac + PGE2 Responders | 1 | 10 |
,Placebo + PGE2 Nonresponders | 15 | 17 |
,Placebo + PGE2 Responders | 4 | 13 |
Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment
Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete. (NCT00118365)
Timeframe: Up to 36 months
Intervention | participants (Number) |
---|
| Yes | No |
---|
Eflornithine and Sulindac + Putrescine Nonresponders | 7 | 53 |
,Eflornithine and Sulindac + Putrescine Responders | 9 | 52 |
,Placebo + Putrescine Nonresponders | 28 | 44 |
,Placebo + Putrescine Responders | 22 | 24 |
Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment
Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by >=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete. (NCT00118365)
Timeframe: Up to 36 months
Intervention | participants (Number) |
---|
| Yes | No |
---|
Eflornithine and Sulindac + Spd:Spm Nonresponders | 8 | 30 |
,Eflornithine and Sulindac + Spd:Spm Responders | 8 | 75 |
,Placebo + Spd:Spm Nonresponders | 33 | 44 |
,Placebo + Spd:Spm Responders | 17 | 24 |
Trials
1 trial available for spermine and Cancer, Second Primary