Page last updated: 2024-10-20

putrescine and Adenoma

putrescine has been researched along with Adenoma in 9 studies

Adenoma: A benign epithelial tumor with a glandular organization.

Research Excerpts

Excerpt	Relevance	Reference
"Histamine was detected in 3 of the 6 cases of thyroid carcinomas, and in case of adenomatous goiter."	5.26	Elevated levels of polyamines and histamine in adenocarcinomas of the thyroid. ( Hamana, K; Itoh, K; Matsuzaki, S; Suzuki, M, 1978)
"Histamine was detected in 3 of the 6 cases of thyroid carcinomas, and in case of adenomatous goiter."	1.26	Elevated levels of polyamines and histamine in adenocarcinomas of the thyroid. ( Hamana, K; Itoh, K; Matsuzaki, S; Suzuki, M, 1978)
"All 6 patients with localized malignant tumors had elevated urinary polyamine levels."	1.25	Urinary polyamine levels in human cancer. ( Kessler, GF; Lipton, A; Sheehan, LM, 1975)

Research

Studies (9)

Timeframe	Studies, this research(%)	All Research%
pre-1990	5 (55.56)	18.7374
1990's	1 (11.11)	18.2507
2000's	1 (11.11)	29.6817
2010's	2 (22.22)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Pan, P	1
Skaer, CW	1
Wang, HT	1
Stirdivant, SM	1
Young, MR	1
Oshima, K	1
Stoner, GD	1
Lechner, JF	1
Huang, YW	1
Wang, LS	1
Thompson, PA	1
Wertheim, BC	1
Zell, JA	1
Chen, WP	1
McLaren, CE	1
LaFleur, BJ	1
Meyskens, FL	1
Gerner, EW	1
Fulton, DS	1
Marton, LJ	2
Lubich, WP	2
Wilson, CB	2
Schleiffer, R	1
Duranton, B	1
Gossé, F	1
Hasselmann, M	1
Raul, F	1
Lipton, A	1
Sheehan, LM	1
Kessler, GF	1
Matsuzaki, S	1
Suzuki, M	1
Hamana, K	1
Itoh, K	1
Heby, O	1
Levin, VA	1
Crafts, DC	1
Tatsuta, M	1
Iishi, H	1
Baba, M	1
Ichii, M	1
Nakaizumi, A	1
Uehara, H	1
Taniguchi, H	1
Yamamoto, O	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

Intervention	nmol/mg protein (Median)
ODC1 AA/GA	1.99
ODC1 GG	2.17

Baseline Spermine by ODC Genotype

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

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 putrescine and Adenoma

Article	Year
Levels of rectal mucosal polyamines and prostaglandin E2 predict ability of DFMO and sulindac to prevent colorectal adenoma. Gastroenterology, 2010, Volume: 139, Issue:3 Topics: Adenoma; Aged; Anticarcinogenic Agents; Biomarkers, Pharmacological; Biopsy; Colonoscopy; Colorectal	2010

Other Studies

8 other studies available for putrescine and Adenoma

Article	Year
Black raspberries suppress colonic adenoma development in ApcMin/+ mice: relation to metabolite profiles. Carcinogenesis, 2015, Volume: 36, Issue:10 Topics: Adenoma; Adenomatous Polyposis Coli Protein; alpha-Linolenic Acid; Animals; Colorectal Neoplasms; Di	2015
Polyamine levels in CSF from patients with pituitary tumors or nonneoplastic pituitary disease. Archives of neurology, 1982, Volume: 39, Issue:1 Topics: Acromegaly; Adenoma; Adenoma, Chromophobe; Adult; Aged; Female; Humans; Male; Middle Aged; Nelson Sy	1982
Blood polyamine levels after oral ornithine load, a diagnostic marker of hyperproliferative premalignant and malignant stages in a model of colon carcinogenesis. Cancer detection and prevention, 2000, Volume: 24, Issue:6 Topics: 1,2-Dimethylhydrazine; Adenocarcinoma; Adenoma; Animals; Biomarkers, Tumor; Biotransformation; Body	2000
Urinary polyamine levels in human cancer. Cancer, 1975, Volume: 35, Issue:2 Topics: Adenocarcinoma; Adenoma; Bone Neoplasms; Breast Neoplasms; Bronchial Neoplasms; Carcinoma, Squamous	1975
Elevated levels of polyamines and histamine in adenocarcinomas of the thyroid. The Journal of clinical endocrinology and metabolism, 1978, Volume: 47, Issue:5 Topics: Adenocarcinoma; Adenoma; Adult; DNA; Female; Graves Disease; Histamine; Humans; Middle Aged; Polyami	1978
The relationship of polyamines in cerebrospinal fluid to the presence of central nervous system tumors. Cancer research, 1976, Volume: 36, Issue:3 Topics: Adenoma; Astrocytoma; Brain Neoplasms; Central Nervous System Diseases; Glioma; Humans; Medulloblast	1976
Inhibition by putrescine of experimental carcinogenesis in rat colon induced by azoxymethane. International journal of cancer, 1991, Mar-12, Volume: 47, Issue:5 Topics: Adenocarcinoma; Adenoma; Animals; Azoxymethane; Body Weight; Carcinoma in Situ; Cell Transformation,	1991
[Ornithine decarboxylase activity and polyamine levels in human thyroid tumor tissue]. Nihon Geka Gakkai zasshi, 1989, Volume: 90, Issue:7 Topics: Adenoma; Adolescent; Adult; Aged; Biogenic Polyamines; Carcinoma; Carcinoma, Papillary; Child; Femal	1989