mTOR Bio-001 - mTOR Biomarker study

• Research type

  Research Study

• Full title

  A study to validate the assay of biomarkers of the mTOR signaling pathway (p- S6RP(Ser240/244) for mTORC1 and p-AKT (Ser473) for mTORC2) and other non-genetic biomarkers in whole blood samples from Patients with Tuberous Sclerosis Complex (TSC)

• IRAS ID

  316411

• Contact name

  Sam Amin

• Contact email

  samamin@nhs.net

• Sponsor organisation

  Aeovian Pharmaceuticals Inc.

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 2 months, 6 days

• Research summary

  This is a Biomarker study. The purpose with this study is to confirm that an analysis of specific chemicals found in blood will be suitable to prove that some new treatments will help patients with Tuberous Sclerosis Complex (TSC). The study will only take place in UK and recruit at least 12 participants, aged 10 to 65 years at the time of signing the ICF, and known to have tuberous sclerosis. There will be no Investigational Medicinal Product (IMP) nor treatment. Participants will have to provide a blood sample of 10ml (about 2 teaspoons) at visit 2. Extra blood will be taken as part of the routine blood tests.
  Participants are required to fast 8 hours (overnight) and avoid drinks containing sugar and alcohol prior to the blood collection.

  Laboratory Analysis:
  As part of standard laboratory practice, participants blood will be screened for the presence of diseases including HIV, Syphilis, Hepatitis B and C. In the unlikely event that a patient with TSC reveals an abnormal result the patients’ GP will be informed via the Principal Investigator and if necessary, support provided.

  At the laboratory, the blood sample is processed into a lysate, excess blood is destroyed, and the lysate is used for the biomarker analysis. Any excess lysate (which is a not relevant material for the purposes of the Human Tissue Act) will be kept for 3 years after the study has completed (unless consent is revoked) in case new information becomes available which will help the biomarker research specified in this protocol

  Planned recruitment end date is end of August 2022 and study end date is planned for 30 September 2022.
  

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  22/SC/0188

• Date of REC Opinion

  22 Jul 2022

• REC opinion

  Further Information Favourable Opinion