Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Recurrence

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Disease Progression

Adenocarcinoma of Lung

Adenocarcinoma, Bronchiolo-Alveolar

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Erlotinib Hydrochloride

gene mapping

polymorphism analysis

diagnostic laboratory biomarker analysis

immunohistochemistry staining method

Jill Kolesar, PharmD

RATIONALE: Studying samples of 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 with erlotinib.

PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.

OBJECTIVES:

* Assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ECOG-E3503.
* Determine the loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients.
* Assess whether mesenchymal and epithelial markers are predictive of progression-free survival (PFS) of these patients.
* Identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS of these patients.

OUTLINE: Tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (SNP) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (E-cadherin) marker transitions. After biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed.

PROJECTED ACCRUAL: A total of 137 samples will be accrued for this study.

Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer

Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503

Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers

Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers

Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS

National Cancer Institute (NCI)

ECOG-ACRIN Cancer Research Group

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Renal Cell

Kidney Neoplasms

Rhabdoid Tumor

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms by Histologic Type

Renal Cell Carcinoma

DNA analysis

fluorescence in situ hybridization

gene expression analysis

microarray analysis

polymerase chain reaction

protein expression analysis

laboratory biomarker analysis

medical chart review

Elizabeth A. Mullen, MD

RATIONALE: Studying samples of tissue from patients with rhabdoid tumors in the laboratory may help doctor learn more about changes that occur in DNA and identify genes related to cancer.

PURPOSE: This research trial studies biomarkers in samples from young patients with rhabdoid tumors.

OBJECTIVES:

* To investigate the expression and function of transposons in 50 primary rhabdoid tumors.

OUTLINE: Freshly frozen rhabdoid tumors will be studied using fluorescence in situ hybridization (FISH) and polymerase chain reaction (PCR) to establish the genomic location of transposons. Protein expression in rhabdoid tumor tissue microarrays is also analyzed.

Studying Biomarkers in Samples From Young Patients With Rhabdoid Tumors

Endogenous DNA Transposition in Rhabdoid Tumors

Children's Oncology Group

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Cola

Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.

DNA stability analysis

Richard M. Goldberg, MD

RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer.

PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer.

OBJECTIVES:

* Determine the adverse prognostic significance of 8p allelic imbalance (AI) in patients with colon cancer.
* Determine if patient prognosis is dependent on the region of 8p AI.
* Perform fine mapping studies to further localize the putative tumor suppressor gene(s) on 8p.
* Perform multicolor FISH to examine the role that 8p loss and 8q gain play in the prognosis of patients whose tumors exhibit 8p AI.

OUTLINE: Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.

Genetic Study in Patients With Stage II or Stage III Colon Cancer

The Clinical and Pathological Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer

NCIC Clinical Trials Group

Alliance for Clinical Trials in Oncology

Colonic Neoplasms

Patients donate blood samples for analysis of colorectal susceptibility genes. Patients also complete a questionnaire regarding family cancer history.

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

Participants do not receive the results of the genetic testing, and the results do not influence the type or duration of treatment.

cytogenetic analysis

Monica M. Bertagnolli, MD

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.

PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.

OBJECTIVES:

* Identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps.
* Correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients.
* Correlate colon neoplasia susceptibility with the presence of COX-2, sPLA2, and DNMT genes in these patients.
* Identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.

Genetic Study of Familial Factors in Patients With Colon Cancer

Familial Factors in the Development of Colon Cancer

Skin and Connective Tissue Diseases

Prostatic Neoplasms

Breast Neoplasms

Small Cell Lung Carcinoma

Disease Susceptibility

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Small Cell Lung Cancer

RATIONALE: Identification of genes that may be associated with developing certain types of cancer may someday provide important information about a person's risk of getting cancer.

PURPOSE: This clinical trial is studying to see if certain genes may be associated with cancer in patients with cancer of the breast, prostate, lung, or colon and siblings of these patients.

OBJECTIVES:

* Gather allele-sharing statistics at approximately 100 candidate loci throughout the human genome most likely to influence genetic risk of cancer.
* Use these allele-sharing statistics to test the interaction of each locus individually with cancer-associated, rare alleles of HRAS1.
* Generalize this approach for one of four cancers (breast, colon, lung, or prostate), using allele-sharing statistics to test the interaction of each locus with every other locus.
* Replicate positive results in a distinct set of sibling pairs with cancer.
* Examine, when loci contributing to risk are detected, the influence of this genetic background on clinical outcomes, such as survival.

OUTLINE: Each patient-sibling pair completes a family history questionnaire about the incidence of cancer in the family. Blood samples are obtained from both the patient and the sibling (and both living parents, if available).

The blood samples are genotyped using approximately 300 micro-satellite markers flanking 100 candidate genes previously implicated in genetic risk for cancer. Certain loci are a priority due to their association with HRAS1: BRCA1 and all known mismatch repair loci; other repair genes, such as ATM; the Bloom's syndrome locus; and the XRCC group. Other genes are also mapped.

Patients do not receive the results of the genetic testing and the results do not influence the type and duration of treatment.

Patients only are followed annually.

PROJECTED ACCRUAL: This study will accrue 1,000 patient-sibling pairs for breast cancer. After 18 months, another 1,000 patient-sibling pairs will be accrued for breast cancer. Therefore, up to 2,000 patient-sibling pairs will be accrued over 5 years. (Feasibility of accruing pairs for lung, colon, and prostate cancer is being assessed.)

Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer

ECOG Laboratory Study: Mapping Interactive Cancer Susceptibility Loci

Eastern Cooperative Oncology Group

Musculoskeletal Diseases

Bone Neoplasms

Chordoma

Neoplasms, Germ Cell and Embryonal

Population-based sampling of individuals affected with Chordoma

Mary L McMaster, M.D.

Chordoma is an uncommon (400 case/year in the U.S.) and potentially fatal bone tumor derived from remnants of embryonic notochord. It occurs primarily in the axial skeleton and has a mean age at diagnosis of 55 years, with a range from early childhood to over 70 years. This tumor usually presents at an advanced stage and the associated mortality is high due to local destruction and distant metastases. Chordoma is rare in African-Americans and is typically sporadic; there are few reports of these tumors arising congenitally or within members of the same family.

Recently, we have identified and studied one large family in which 10 relatives in three generations have chordoma; the inheritance pattern suggests transmission of a mutation in an autosomal dominant gene. Using information from this family, we have tentatively napped this gene to the long arm of chromosome 7. To confirm this finding, and to fine map and clone the gene, we need to study additional chordoma families. In an effort to identify such families, we have developed collaborations with four SEER registries covering the populations of Detroit, Los Angeles, Iowa, and New Mexico. Each registry will identify all chordoma cases diagnosed since 1988 and invite them (or the next of kin of deceased cases) to participate in our study. Through 1997, the registries have identified a total of 140 chordoma cases, 96 of whom are living. The registries will invite these patients (or their next of kin) to participate in the study. The study components include completion of a self-administered personal and family medical history questionnaire, retrieval of medical records and pathology reports pertaining to chordoma, and collection of paraffin-embedded chordoma tissue and buccal mucosal cells for genetic studies. NCI will carry out all the data collection activities for the study subjects identified through the Detroit registry. NCI will also conduct the buccal cell collection component of the study for all patients identified by the other three registries. These three registries will carry out all other study activities on these patients/next of kin and will send the data and slides prepared from the paraffin blocks to NCI. NCI will analyze the questionnaire data to determine if any unusual patterns of cancers other than chordoma or other medical conditions appear to cluster in families of the chordoma patients. Selected members of any families with two or more relatives with chordoma will be invited to participate in a separate clinical and molecular study conducted at NIH to try to identify the chordoma gene. DNA from the buccal cells and tumor blocks from all other patients with "sporadic" chordoma identified through the registries (likely to comprise most patients) will not be studied until we or others have identified such a gene.

Chordoma is an uncommon (400 case/year in the U.S.) and potentially fatal bone tumor derived from remnants of embryonic notochord. It occurs primarily in the axial skeleton and has a mean age at diagnosis of 55 years, with a range from early childhood to over 70 years. This tumor usually presents at an advanced stage and the associated mortality is high due to local destruction and distant metastases. Chordoma is rare in African-Americans and is typically sporadic; there are few reports of these tumors arising congenitally or within members of the same family.

In 1996, we have identified and studied one large family in which 8 relatives in three generations have chordoma; the inheritance pattern suggests transmission of a mutation in an autosomal dominant gene. Using information from this family, we tentatively mapped this gene to the long arm of chromosome 7. To confirm this finding, and to fine map and clone the gene, we needed to study additional chordoma families.

In an effort to identify such families, we have developed collaborations with four SEER registries covering the populations of Detroit, Los Angeles, Iowa, and New Mexico. Each registry will identify all chordoma cases diagnosed since 1988 and invite them (or the next of kin of deceased cases) to participate in our study. Through 1997, the registries have identified a total of 140 chordoma cases, 96 of whom are living. The registries will invite these patients (or their next of kin) to participate in the study. The study components included completion of a self-administered personal and family medical history questionnaire, retrieval of medical records and pathology reports pertaining to chordoma, and collection of paraffin-embedded chordoma tissue and buccal mucosal cells for genetic studies. NCI carried out all the data collection activities for the study subjects identified through the Detroit registry. NCI also conducted the buccal cell collection component of the study for all patients identified by the other three registries. These three registries will carry out all other study activities on these patients/next of kin and sent the data and slides prepared from the paraffin blocks to NCI. NCI will analyze the questionnaire data to determine if any unusual patterns of cancers other than chordoma or other medical conditions appear to cluster in families of the chordoma patients. Selected members of any families with two or more relatives with chordoma will be invited to participate in a separate clinical and molecular study conducted at NIH to try to identify the chordoma gene. DNA from the buccal cells and tumor blocks from all other patients with 'sporadic' chordoma identified through the registries (likely to comprise most patients) will not be studied until we or others have identified such a gene.

Genetic Aspects of Chordoma: A Collaboration With SEER Registries to Identify Chordoma Families

To determine if any unusual patterns of cancers other than chordoma or other medical conditions appear to cluster in families of the chordoma patients with the ultimate, long-term goal fine-mappingthe gene(s) involved in chordoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer	NCT00897533	Lung Cancer	gene mapping polymorphism an... diagnostic labo... immunohistochem...	- 120 Years	Eastern Cooperative Oncology Group
Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer	NCT00897533	Lung Cancer	gene mapping polymorphism an... diagnostic labo... immunohistochem...	- 120 Years	Eastern Cooperative Oncology Group
Studying Biomarkers in Samples From Young Patients With Rhabdoid Tumors	NCT01544569	Kidney Cancer	DNA analysis fluorescence in... gene expression... gene mapping microarray anal... polymerase chai... protein express... laboratory biom... medical chart r...	- 1 Year	Children's Oncology Group
Genetic Study in Patients With Stage II or Stage III Colon Cancer	NCT00003833	Colorectal Canc...	DNA stability a... gene mapping	- 69 Years	Alliance for Clinical Trials in Oncology
Genetic Study in Patients With Stage II or Stage III Colon Cancer	NCT00003833	Colorectal Canc...	DNA stability a... gene mapping	- 69 Years	Alliance for Clinical Trials in Oncology
Genetic Study of Familial Factors in Patients With Colon Cancer	NCT00055848	Colorectal Canc...	cytogenetic ana... gene mapping microarray anal...	- 70 Years	Alliance for Clinical Trials in Oncology
Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer	NCT00003329	Breast Cancer Colorectal Canc... Lung Cancer Prostate Cancer	gene mapping	0 Years - 120 Years	Eastern Cooperative Oncology Group
Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer	NCT00003329	Breast Cancer Colorectal Canc... Lung Cancer Prostate Cancer	gene mapping	0 Years - 120 Years	Eastern Cooperative Oncology Group
Identification of Genes Associated With Cancer in Patients and Siblings Who Have Cancer	NCT00003329	Breast Cancer Colorectal Canc... Lung Cancer Prostate Cancer	gene mapping	0 Years - 120 Years	Eastern Cooperative Oncology Group
Genetic Aspects of Chordoma: A Collaboration With SEER Registries to Identify Chordoma Families	NCT00341627	Chordoma		- 110 Years	National Institutes of Health Clinical Center (CC)

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