NCT02632084

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

December 10, 2015

Last Update Submit

December 11, 2015

Conditions

Pituitary Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Tumour size on MRI scan.

    6 months

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who were not included in the above mentioned trials. Patients included in the original trials who have subsequently died (of any cause).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3HE,, United Kingdom

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2015

First Posted

December 16, 2015

Study Start

March 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2011

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations

GB(1)