Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Adenocarcinoma

Microsatellite Instability

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline.

The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance.

Patients may be referred for genetic counseling.

microsatellite instability analysis

Jose G. Guillem, MD

RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age.

PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I, stage II, or stage III colorectal cancer at an early age.

OBJECTIVES:

* Evaluate the prognostic significance (e.g., overall survival) of microsatellite instability (MSI) status in patients with early age-of-onset stage I-III colorectal cancer, assuming the presence of a quantitative interaction between MSI status and family history of cancer.
* Evaluate the development of metachronous neoplasms in this patient population.
* Evaluate the histologic features and genetic changes associated with hereditary nonpolyposis colorectal cancer in this patient population.

OUTLINE: This is a multicenter study. Patients are stratified according to family history using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer (positive vs negative).

Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline.

The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance.

Patients may be referred for genetic counseling.

A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.

Genetic Study of Young Patients With Colorectal Cancer

A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Carcinoma

Genomic Instability

Immunohistochemical analysis was performed for Microsatellite Instability (MSI) status of colorectal tumors tissue.

Molecular analysis for Microsatellite Instability (MSI) status was performed using immunohistochemistry (IHC). IHC now recognized as an approved method to highly precision predict MSI in colorectal cancer.

Microsatellite instability analysis

Taygun Gülşen, MD

In this study, we aimed to identify the different histopathological features of tumors with microsatellite instability (MSI) compared to microsatellite stable (MSS) in patients who underwent surgery for colorectal cancer. We also planned to determine how MSI affects prognostic parameters.

According to Global Cancer Statistics, higher than 1.9 million new cases of colorectal cancer (CRC) and 935,000 deaths are estimated to occur in 2020, representing about one in 10 cancer cases and deaths. Overall, it ranks third in colorectal incidence but second in mortality.

In CRC evolution, the acquisition of genomic instability is a critical point, and there are at least two different pathways in the pathogenesis of CRC: the chromosomal instability (CIN) pathway (85%) and the microsatellite instability (MSI) pathway (15%).

Microsatellite instability (MSI) is a phenotype that occurs due to a malfunction in the DNA repair mechanism and is seen in approximately 15% of colorectal cancers (CRCs). CRCs with MSI have different clinical features, such as a tendency to settle in the proximal colon, poor differentiation, and more lymphocytic infiltration in the tumor. It has been shown that CRCs with MSI have a better prognosis and respond differently to chemotherapy than CRCs with microsatellite stable (MSS).

We aimed to evaluate the different histopathological features of tumors with MSI compared to MSS in patients who underwent surgery for colorectal cancer. We also planned to determine how MSI affects prognostic parameters such as mortality rate, recurrence, disease-free survival, cancer-specific survival, and overall survival.

Microsatellite Instability in Colorectal Cancers

Clinicopathological Outcomes of Microsatellite Instability in Colorectal Cancer

Overall survival is defined as the time interval from the time of primary operation to the date of all-cause death or the last follow-up.

Disease-Free Survival is defined as the time interval from the time of primary operation to disease recurrence or death.

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

MD, General Surgeon

loss of heterozygosity analysis

mutation analysis

counseling intervention

Donald W. Hadley, MS, CGC

RATIONALE: Identifying family and individual characteristics may help plan education and counseling for patients who are considering genetic testing.

PURPOSE: This clinical trial is studying education and counseling to see what effect they have in patients who are undergoing genetic testing for hereditary nonpolyposis colon cancer (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within families already participating continues).

OBJECTIVES:

* Identify family characteristics, personality traits, and religious and spiritual beliefs that significantly affect individual decisions regarding mutation testing for hereditary nonpolyposis colon cancer (HNPCC) (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within families already participating continues).
* Determine the impact of negative vs positive mutation test results on family relationships and psychological status.
* Assess expectations regarding testing and how they influence perceptions of risks and responses to risk notification.
* Determine the impact of risk notification on the frequency of screening/prevention activities.
* Formulate a standard diagnostic algorithm for determining microsatellite instability based on the analysis of tumors with this extensive array of markers and correlate specific replication error phenotypes with germline genotype.

OUTLINE: Participants complete a baseline assessment of knowledge, risk perception, and personality traits followed by a structured pretest education session. Participants are then offered the choice of whether or not to undergo genetic testing for mutations in hereditary nonpolyposis colon cancer (HNPCC) genes. Participants who choose to undergo genetic testing provide a blood sample for this purpose. Participants who undergo genetic testing receive results and counseling (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within families already participating continues).

Available surveillance options are discussed for all participants. Psychological and behavioral outcomes are reassessed at 6 and 12 months for both those choosing and not choosing genetic testing.

Tumors (when available) are analyzed for mismatched repair deficiency on the basis of microsatellite instability.

PROJECTED ACCRUAL: A total of 900 participants will be accrued for this study, with a specific target of 200 individuals who have not experienced cancer within families identified with hereditary nonpolyposis colon cancer (HNPCC) mutations (recruitment of new families with HNPCC stopped as of 04-26-06, recruitment of persons within families already participating continues).

Study of the Results of Education and Counseling for Persons Undergoing Genetic Testing for Hereditary Nonpolyposis Colon Cancer

Outcomes in Education and Counseling for HNPCC Testing

National Human Genome Research Institute (NHGRI)

Recurrence

Antineoplastic Agents

Bevacizumab

Fluorouracil

Oxaliplatin

DNA methylation analysis

laboratory biomarker analysis

Stanley Hamilton, MD

RATIONALE: Studying samples of blood, urine, and 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 predict how patients respond to treatment.

PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.

OBJECTIVES:

* Determine the CpG island methylation pathway markers that are adverse for survival after treatment with fluorouracil in patients with advanced colorectal adenocarcinoma treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.
* Compare the methylation results to clinicopathologic and molecular findings and survival.

OUTLINE: This is a multicenter study.

Tissue, blood, and urine samples and genomic DNA samples from tumor tissue blocks are examined by pyrosequencing assay for methylation. Genes examined include MINT1, MINT31, P14, and P16. Microsatellite instability and loss of heterozygosity (LOH) on chromosome 18 (18q LOH) are also assessed. Microsatellites examined include BAT loci, TGFβRII, D2S123, D55346, and D17S250.

PROJECTED ACCRUAL: A total of 350 specimens will be accrued for this study.

Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200

Evaluation of the Association Between DNA Methylation and Shortened Survival in Patients With Advanced Colorectal Cancer Treated With 5-FU/Oxaliplatin-Based Regimens in E3200

ECOG-ACRIN Cancer Research Group

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

microarray analysis

cytology specimen collection procedure

computed tomography

cystoscopy

Mark P. Schoenberg, MD

RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in the urine may improve the ability to detect bladder cancer without invasive procedures.

PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sediment in the urine in detecting bladder cancer in healthy participants, participants who have genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.

OBJECTIVES:

Primary

* Compare the sensitivity and specificity of microsatellite analysis (MSA) of urine sediment with cystoscopy and urine cytology for detecting bladder cancer in participants undergoing cystoscopy.

Secondary

* Determine the temporal performance characteristics of MSA in urine sediment from these participants.
* Determine which of the 15 individual markers or combination of markers that make up the MSA test are most predictive of the presence of bladder cancer in these participants.

OUTLINE: This is a single-blind, multicenter, cohort study.

Urine and blood specimens are collected from all participants at baseline. Urine specimens are examined using microsatellite analysis, urine cytology, and urinalysis. Patients in groups 2 and 3 also undergo cystoscopy at baseline.

Patients in group 3 undergo cystoscopy, upper tract imaging (e.g., abdominal CT scan), microsatellite analysis, urine cytology, and urinalysis every 3 months for 2 years in the absence of progressive disease.

Microsatellite analysis, which identifies loss of heterozygosity using polymerase chain reaction technique, is conducted for 15 markers: D4S243, D21S1245, FGA, D17S695, D16S476, D9S171, IFN-A, D20S48, D13S802, D17S654, D16S310, THO1, D9S162, D9S747, and MBP.

PROJECTED ACCRUAL: A total of 500 participants (100 each for groups 1 and 2 and 300 for group 3) will be accrued for this study.

Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer

Detection of Bladder Cancer by Microsatellite Analysis (MSA) of Urinary Sediment: Multi-Institutional Study

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Genetic Study of Young Patients With Colorectal Cancer	NCT00044967	Colorectal Canc...	microsatellite ...	18 Years - 49 Years	Alliance for Clinical Trials in Oncology
Microsatellite Instability in Colorectal Cancers	NCT05162248	Colorectal Canc... Colorectal Carc... Microsatellite ... Microsatellite ... Microsatellite ...	Microsatellite ...	18 Years - 100 Years	Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Study of the Results of Education and Counseling for Persons Undergoing Genetic Testing for Hereditary Nonpolyposis Colon Cancer	NCT00004210	Colorectal Canc...	loss of heteroz... microsatellite ... mutation analys... counseling inte...	18 Years -	National Cancer Institute (NCI)
Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200	NCT00897819	Colorectal Canc...	DNA methylation... loss of heteroz... microsatellite ... laboratory biom...	18 Years - 120 Years	Eastern Cooperative Oncology Group
Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer	NCT00095589	Bladder Cancer	loss of heteroz... microarray anal... microsatellite ... cytology specim... laboratory biom... computed tomogr... cystoscopy	40 Years - 120 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study of the Results of Education and Counseling for Persons Undergoing Genetic Testing for Hereditary Nonpolyposis Colon Cancer	NCT00004210	Colorectal Canc...	loss of heteroz... microsatellite ... mutation analys... counseling inte...	18 Years -	National Cancer Institute (NCI)
Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer	NCT00095589	Bladder Cancer	loss of heteroz... microarray anal... microsatellite ... cytology specim... laboratory biom... computed tomogr... cystoscopy	40 Years - 120 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Genetic Study of Young Patients With Colorectal Cancer	NCT00044967	Colorectal Canc...	microsatellite ...	18 Years - 49 Years	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for microsatellite instability analysis