NCT00503893

Brief Summary

The goal of this clinical research study is to collect information and blood samples to try to learn why some people develop cancers and tumors, why some families have more cancers than others, and whether certain genes or regions of DNA (the genetic material of cells) affect a person's risk of getting cancer. This is an investigational study. Up to 1500 patients and family members will take part in this study. All will be enrolled at MD Anderson.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
295

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 1980

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1980

Completed
26.6 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

40 years

First QC Date

July 17, 2007

Last Update Submit

January 23, 2020

Conditions

Keywords

Wilms' TumorGenitourinary AnomaliesBeckwith-Wiedemann HemihypertrophyAniridiaQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Genetic Events Involved in Development of Wilms' tumor, Genitourinary Anomalies, Hemihypertrophy and Beckwith-Wiedemann, and/or Aniridia

    Characterize genetic events by a combined molecular biology/epidemiologic approach

    32 Years (Descriptive data collected using questionnaires)

Study Arms (1)

Wilm's Tumor PO1

Familial and Sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia.

Behavioral: QuestionnaireOther: Blood specimen

Interventions

QuestionnaireBEHAVIORAL

Questionnaire regarding medical history and family medical history that will take about 1 hour to complete.

Also known as: Survey
Wilm's Tumor PO1

Blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time.

Wilm's Tumor PO1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.

You may qualify if:

  • \. Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample(s) for genetic testing. Also, tissue samples, and/or bodily fluids (whether healthy or cancerous) left over from surgeries or procedures performed as part of standard care. The purpose of this clinical research study is to find out why some people develop cancers and tumors, why some families have more cancers than others, and whether certain genes or regions of DNA affect a person's risk of getting cancer.

MeSH Terms

Conditions

Wilms TumorAniridiaUrogenital Abnormalities

Interventions

Surveys and QuestionnairesBlood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEye AbnormalitiesEye DiseasesEye Diseases, HereditaryIris DiseasesUveal DiseasesCongenital Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, Operative

Study Officials

  • Louise C. Strong, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

December 1, 1980

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations