Wilms' TumorNCT00503893
Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies
An observational study of Wilms' Tumor and Aniridia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wilms' Tumor, Aniridia
- What is being tested?
- Questionnaire and Blood specimen
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 295 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 1980to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.
Who may be able to join
- 1. Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.
Who cannot join
- 1. Patients who do not meet inclusion eligibility criteria are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the detailed description
If you choose to take part in this study, blood (about 10 teaspoons) will be drawn for genetic testing. The blood may be drawn more than 1 time, depending on how much blood is drawn at the first visit, and if you are available for more blood draws. If this is the case, your doctor will discuss any extra blood draws with you.
For small children (less than 5 years old), about 2 teaspoons will be drawn. Children who are 5 years old or older will not have more than 3 teaspoons drawn.
You will complete a questionnaire about your medical history and family medical history. The questionnaire should take about 1 hour to complete. The study staff will also review your medical records.
You will be asked to allow the study staff to collect any of your tissue (whether healthy or cancerous) that is leftover from surgeries performed as part of your standard care. This may be from any past or future surgeries or any tissue being stored at MD Anderson or elsewhere. No new surgeries or biopsies will be performed for this study.
Before your information, tissue samples, and/or bodily fluids can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your information, tissue samples, and/or bodily fluids, must first be approved by the IRB.
You may be contacted either by phone or mail 1 time a year, so that the study staff can update your medical history and information. If contacted by phone, this call should last about 30 minutes.
- Conditions
- Wilms' Tumor, Aniridia
- Being tested
- Questionnaire, Blood specimen
- Keywords
- Wilms' Tumor, Genitourinary Anomalies, Beckwith-Wiedemann Hemihypertrophy, Aniridia, Questionnaire
- Medical subject headings
- Wilms Tumor, Aniridia, Urogenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaire regarding medical history and family medical history that will take about 1 hour to complete.
Blood specimenOther
Blood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time.
| Study group | Role | What they receive |
|---|---|---|
| Wilm's Tumor PO1 | Familial and Sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia. Receives: Behavioral: Questionnaire; Other: Blood specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 32 Years (Descriptive data collected using questionnaires)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study start1 Dec 1980
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilms' TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Louise C. Strong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503893
- Sponsor's protocol ID
- P80-099
- Other IDs
- P01CA034936-23
- Status last verified
- Jan 2020
- First submitted
- 17 Jul 2007
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies
- ClinicalTrials.gov ID
- NCT00503893
- Acronym / sponsor ID
- P80-099
- Conditions
- Wilms' Tumor, Aniridia
- Keywords
- Wilms' Tumor, Genitourinary Anomalies, Beckwith-Wiedemann Hemihypertrophy, Aniridia, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 295 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Dec 1980 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
If you choose to take part in this study, blood (about 10 teaspoons) will be drawn for genetic testing. The blood may be drawn more than 1 time, depending on how much blood is drawn at the first visit, and if you are available for more blood draws. If this is the case, your doctor will discuss any extra blood draws with you.
For small children (less than 5 years old), about 2 teaspoons will be drawn. Children who are 5 years old or older will not have more than 3 teaspoons drawn.
You will complete a questionnaire about your medical history and family medical history. The questionnaire should take about 1 hour to complete. The study staff will also review your medical records.
You will be asked to allow the study staff to collect any of your tissue (whether healthy or cancerous) that is leftover from surgeries performed as part of your standard care. This may be from any past or future surgeries or any tissue being stored at MD Anderson or elsewhere. No new surgeries or biopsies will be performed for this study.
Before your information, tissue samples, and/or bodily fluids can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your information, tissue samples, and/or bodily fluids, must first be approved by the IRB.
You may be contacted either by phone or mail 1 time a year, so that the study staff can update your medical history and information. If contacted by phone, this call should last about 30 minutes.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wilm's Tumor PO1 | – | Behavioral: Questionnaire, Other: Blood specimenFamilial and Sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.
Key inclusion criteria (1 listed)
- 1. Patients with familial and sporadic Wilm's tumor, genitourinary anomalies, Beckwith-Wiedemann hemihypertrophy and/or aniridia, and family members of patients.
Key exclusion criteria (1 listed)
- 1. Patients who do not meet inclusion eligibility criteria are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire regarding medical history and family medical history that will take about 1 hour to complete. | Behavioural | Wilm's Tumor PO1 |
| Blood specimenBlood (about 10 teaspoons) will be drawn from a vein for genetic testing. The blood may be drawn more than one time. | Other | Wilm's Tumor PO1 |
Primary outcome
Genetic Events Involved in Development of Wilms' tumor, Genitourinary Anomalies, Hemihypertrophy and Beckwith-Wiedemann, and/or Aniridia
Time frame: 32 Years (Descriptive data collected using questionnaires)
Characterize genetic events by a combined molecular biology/epidemiologic approach
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise C. Strong, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilms' Tumor and Aniridia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Events Involved in Development of Wilms' tumor, Genitourinary Anomalies, Hemihypertrophy and Beckwith-Wiedemann, and/or Aniridia (time frame: 32 Years (Descriptive data collected using questionnaires)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.