RadiotherapyNCT00457210
The Influence of Radiotherapy on Cognitive Function
An observational study of Radiotherapy and Brain Neoplasms, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Radiotherapy, Brain Neoplasms, Quality of Life
- What is being tested?
- Brain Radiotherapy/Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to not given
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-80 years old oncologic patients, of both genders, that are referred to Brain Radiotherapy or Stereotactic Radiosurgery due to primary brain tumor/ brain metastases or increased risk for brain metastases.
- Are able to follow instructions in Hebrew.
Who cannot join
- Non-Hebrew speakers can not participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the Radiotherapy or Stereotactic Radiosurgery on the Cognitive Function of the Patients With the Neurotrax Assessment System and a Cognitive Questionnaire.
The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment.
Read the detailed description
The basic cognitive function and QOL of 150 oncologic patients that undergone Radiotherapy or Radiosurgery treatment to the brain due to primary tumor, metastases or increased risk of brain metastases, will be assessed at 3 time points: before the treatment, immediately after the treatment, and on the next follow up visit. The assessment tools that will be used are Neurotrax standard cognitive computerized tests and 2 short questionnaires.Patients that will receive a one-day treatment will be tested on 2 time points only- before the treatment and on FU.The research will reveal the positive and the negative influences of the Radiotherapy, along with the assessment of norms for the cognitive function and quality of life of oncologic patients being treated by RT.Eligibility criteria:oncologic patients of both genders, with primary brain tumors, metastases or with increased risk of brain metastases, that are referred to conformal/palliative or preventive Radiotherapy treatment or to Stereotactic Radiosurgery, who are able to follow instructions in Hebrew.The participants will be 20-80 years old.Main comparisons will be performed between the cognitive tests results on 3 time points mentioned. The study will continue until the needed number of participants will be achieved.
- Conditions
- Radiotherapy, Brain Neoplasms, Quality of Life
- Being tested
- Brain Radiotherapy/Stereotactic Radiosurgery
- Keywords
- Psychology
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Radiotherapy/Stereotactic RadiosurgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical 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
- Defined population
- Time perspective
- Other
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Mindstreams
- Investigators
- Ben Corn, PhD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457210
- Sponsor's protocol ID
- TASMC-07-BC-040-CTIL
- Status last verified
- Apr 2007
- First submitted
- 5 Apr 2007
- Last updated
- 6 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Radiotherapy or Stereotactic Radiosurgery on the Cognitive Function of the Patients With the Neurotrax Assessment System and a Cognitive Questionnaire.
- ClinicalTrials.gov ID
- NCT00457210
- Acronym / sponsor ID
- TASMC-07-BC-040-CTIL
- Conditions
- Radiotherapy, Brain Neoplasms, Quality of Life
- Keywords
- Psychology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Mindstreams
- Study start
- Apr 2007
- First posted
- 6 Apr 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 cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment.
Detailed description
The basic cognitive function and QOL of 150 oncologic patients that undergone Radiotherapy or Radiosurgery treatment to the brain due to primary tumor, metastases or increased risk of brain metastases, will be assessed at 3 time points: before the treatment, immediately after the treatment, and on the next follow up visit. The assessment tools that will be used are Neurotrax standard cognitive computerized tests and 2 short questionnaires.Patients that will receive a one-day treatment will be tested on 2 time points only- before the treatment and on FU.The research will reveal the positive and the negative influences of the Radiotherapy, along with the assessment of norms for the cognitive function and quality of life of oncologic patients being treated by RT.Eligibility criteria:oncologic patients of both genders, with primary brain tumors, metastases or with increased risk of brain metastases, that are referred to conformal/palliative or preventive Radiotherapy treatment or to Stereotactic Radiosurgery, who are able to follow instructions in Hebrew.The participants will be 20-80 years old.Main comparisons will be performed between the cognitive tests results on 3 time points mentioned. The study will continue until the needed number of participants will be achieved.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20-80 years old oncologic patients, of both genders, that are referred to Brain Radiotherapy or Stereotactic Radiosurgery due to primary brain tumor/ brain metastases or increased risk for brain metastases.
- Are able to follow instructions in Hebrew.
Key exclusion criteria (1 listed)
- Non-Hebrew speakers can not participate.
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 |
|---|---|---|
| Brain Radiotherapy/Stereotactic Radiosurgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2007.
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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.
Ben Corn, PhD principal investigator
Tel-Aviv Sourasky Medical 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 Radiotherapy and Brain Neoplasms, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 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 6 Apr 2007. 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 Israel. 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?
Contact Ben Corn, MD (972-52-426-6533, bencorn@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 6 Apr 2007.