Pituitary NeoplasmsNCT02632084
Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours
An observational study of Pituitary Neoplasms, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
A study to followup patients that have previously been treated for pituitary tumours with either photodynamic therapy or placebo in a previous trial. The study aims to determine whether photodynamic therapy has any long term effect on tumour size, visual fields or endocrinological function. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pituitary Neoplasms
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Sep 2011
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Details of previous research participants will be extracted from the study files by the researchers, who are all members of the direct care team.
Who may be able to join
- Patients who were previously included in the initial pituitary PDT trial, in addition to those who were randomised as part of the RCT arm of the study. These patients have already participated in phase I/II trials. Of note, these patients all have pituitary tumours.
Who cannot join
- Patients who were not included in the above mentioned trials. Patients included in the original trials who have subsequently died (of any cause).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3HE,
About this study
A study to followup patients that have previously been treated for pituitary tumours with either photodynamic therapy or placebo in a previous trial. The study aims to determine whether photodynamic therapy has any long term effect on tumour size, visual fields or endocrinological function.
Read the detailed description
No patients will receive any medical or procedural treatments in this study, since these have been administered in a previous trial. The previous trial participants will be contacted and asked to attend a clinic or to have a telephone interview, where they will answer a questionnaire. They will be assessed clinically for visual fields, as well as undergoing an MRI scan of their head to assess tumour size (unless they have had a scan anyway in the previous 12 months), these tests would ordinarily form part of the routine outpatient workup for patients with pituitary tumours. There is no significant risk to the physical well-being of the patients with any of the methods to be used.
- Conditions
- Pituitary Neoplasms
- Medical subject headings
- Pituitary Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour size on MRI scan.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary NeoplasmsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632084
- Sponsor's protocol ID
- NE13/10696
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours
- ClinicalTrials.gov ID
- NCT02632084
- Acronym / sponsor ID
- NE13/10696
- Conditions
- Pituitary Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Dec 2015 (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.
A study to followup patients that have previously been treated for pituitary tumours with either photodynamic therapy or placebo in a previous trial. The study aims to determine whether photodynamic therapy has any long term effect on tumour size, visual fields or endocrinological function.
Detailed description
No patients will receive any medical or procedural treatments in this study, since these have been administered in a previous trial. The previous trial participants will be contacted and asked to attend a clinic or to have a telephone interview, where they will answer a questionnaire. They will be assessed clinically for visual fields, as well as undergoing an MRI scan of their head to assess tumour size (unless they have had a scan anyway in the previous 12 months), these tests would ordinarily form part of the routine outpatient workup for patients with pituitary tumours. There is no significant risk to the physical well-being of the patients with any of the methods to be used.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Details of previous research participants will be extracted from the study files by the researchers, who are all members of the direct care team.
Key inclusion criteria (1 listed)
- Patients who were previously included in the initial pituitary PDT trial, in addition to those who were randomised as part of the RCT arm of the study. These patients have already participated in phase I/II trials. Of note, these patients all have pituitary tumours.
Key exclusion criteria (1 listed)
- Patients who were not included in the above mentioned trials. Patients included in the original trials who have subsequently died (of any cause).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumour size on MRI scan.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pituitary Neoplasms, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 16 Dec 2015. 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tumour size on MRI scan. (time frame: 6 months). 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 16 Dec 2015.