Completed

Study Description:

It is hypothesized that early changes in the immune system in New Onset Type 1 Diabetes Mellitus (NOT1D) subjects can be detected in immune cells from the inguinal lymph nodes (iLN), which will be distinct from changes observed in peripheral blood derived immune cells. Therefore this study will assess and compare the molecular immune profile of cells derived from the iLN in healthy and NOT1D subjects, to understand the immunological processes that may lead to beta cell destruction. It is a multi-center, non-drug treatment study. Up to 15 subjects in each group, namely healthy subjects and NOT1D subjects, will be evaluated in the study. A data look will be carried out after the recruitment of a cohort of up to 5 healthy subjects, to determine if the quality and quantity of cells derived from aspirate or core biopsy or from peripheral blood are likely to be sufficient to continue the study to meet its primary objective. An interim analysis will be carried out after the recruitment of 5 evaluable healthy subjects and 5 evaluable NOT1D subjects. The primary purpose of this interim analysis will be to facilitate decision making and study design for a potential follow-up interventional study.

GSK Study ID:

203158


ClinicalTrials.gov Identifier:

NCT02801942


EudraCT Number:

Not Available


Study Overview

Medical Conditions

Endocrine - Other

Product

N/A

Collaborators

N/A


Date

July 2016 to December 2017

Type

Interventional

Phase

N/A


Gender

All

Age

18 years - 40 years

Accepts Healthy Volunteers

Yes


This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

United Kingdom, Cambridge CB2 0QQCompleted
United Kingdom, Cambridge CB2 0QCompleted
United Kingdom, Cardiff CF14 4Completed
United Kingdom, Cardiff CF14 4XNCompleted

Study Design

  • Primary Purpose: Basic Science
  • Allocation: Non-randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Percentage of leukocyte subsets including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including B-cells, clusters of differentiation 56 positive (CD56+) CD16+ , CD56bright Natural Killer (NK) cells, CD56lo CD16+, CD56lo CD16 negative (CD56lo CD16-), Dendritic cells, NK Cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including B-cells, CD56+ CD16+, CD56bright NK cells, CD56lo CD16+, CD56lo CD16-, Dendritic cells, NK cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD56+CD16+, CD56bright NK cells, CD56lo CD16+ and CD56lo CD16- in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD56+CD16+, CD56bright NK cells CD56lo CD16+ and CD56lo CD16- in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including Myeloid Dendritic cells and Plasmacytoid Dendritic cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including Myeloid Dendritic cells and Plasmacytoid Dendritic cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD14+ CD16+ monocytes, CD14+ monocytes, and CD16+ monocytes in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD14+ CD16+ monocytes, CD14+ monocytes and CD16+ monocytes in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including programmed death 1 (PD-1)+ inducible costimulator (ICOS)+ follicular helper T (TFH) cell-like Regulatory (Reg) T cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including PD-1+ ICOS+ TFH cell-like Reg T cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including PD-1+ ICOS+ TFH Cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including PD-1+ ICOS+ TFH Cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including Central Memory Conventional (Conv) T cells, Effector Memory Conv T cells, Naive Conv T cells and Stem cell Memory-like Conv T cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including Central Memory Conv T cells, Effector Memory Conv T cells, Naive Conv T cells and Stem cell Memory-like Conv T cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including TFH cells, PD-1+ ICOS+ TFH cells, Type 17 T helper (TH17) cells, TH1 cells, TH1 TH17 cells, TH1 TH17 TH2 T cells, TH1 TH2 cells, TH2 cells, and TH22 cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including TFH cells, PD-1+ ICOS+ TFH cells, Type 17 T helper (TH17) cells, TH1 cells, TH1 TH17 cells, TH1 TH17 TH2 T cells, TH1 TH2 cells, TH2 cells, and TH22 cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including TFH cells, PD-1+ ICOS+ TFH cells, TH1 cells, TH1 TH17 cells, TH1 TH17 TH2 cells, TH1 TH2 cells, TH17 cells, TH2 cells and TH22 cells-like Reg T cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including TFH cells, PD-1+ ICOS+ TFH cells, TH1 cells, TH1 TH17 cells, TH1 TH17 TH2 cells, TH1 TH2 cells, TH17 cells, TH2 cells and TH22 cells-like Reg T cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including Reg T cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including Reg T cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD69+ CD8 and antigen Ki67 (Ki67)+ CD8 in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD69+ CD8 and antigen Ki67 (Ki67)+ CD8 in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD15s+ Reg T cells, CD69+ Reg T cells, Helios+ Reg T cells, Ki67+ T Reg cells, Memory Reg T cells and Resting Reg T cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD15s+ Reg T cells, CD69+ Reg T cells, Helios+ Reg T cells, Ki67+ T Reg cells, Memory Reg T cells and Resting Reg T cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD15s+ Conv T cells, CD69+ Conv T cells, Helios+ Conv T cells and Ki67+ Conv T cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD15s+ Conv T cells, CD69+ Conv T cells, Helios+ Conv T cells and Ki67+ Conv T cells in iLN
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD15s+ Memory Conv T cells, CD69+ Memory Conv T cells, Helios+ Memory Conv T cells and Ki67+ Memory Conv T cells in blood
    Timeframe: Pre Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD15s+ Memory Conv T cells, CD69+ Memory Conv T cells, Helios+ Memory Conv T cells and Ki67+ Memory Conv T cells in iLN
    Timeframe: Biopsy session on Day 1

Secondary Outcomes:

  • Percentage of leukocyte subsets including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including B-cells, CD56+ CD16+, CD56bright NK cells, CD56lo CD16+, CD56lo CD16, Dendritic cells, NK Cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD56+CD16+, CD56br NK cells CD56lo CD16+ and CD56lo CD16- in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including Myeloid Dendritic cells and Plasmacytoid Dendritic cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD14+ CD16+ monocytes, CD14+ monocytes and CD16+ monocytes in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including PD-1+ ICOS+ TFH cell-like Reg T Cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including PD-1+ ICOS+ TFH cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including TFH cells, PD-1+ ICOS+ TFH cells, TH17 cells, TH1 cells, TH1 TH17 cells, TH1 TH17 TH2 T cells, TH1 TH2 cells, TH2 cells, and TH22 cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including TFH cells, PD-1+ ICOS+ TFH cells, TH1 cells, TH1 TH17 cells, TH1 TH17 TH2 cells, TH1 TH2 cells, TH17 cells, TH2 cells and TH22 cells-like Reg T cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including Reg T cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD69+ CD8 and antigen Ki67 (Ki67)+ CD8 in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD15s+ Reg T cells, CD69+ Reg T cells, Helios+ Reg T cells, Ki67+ T Reg cells, Memory Reg T cells and Resting Reg T cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD15s+ Conv T cells, CD69+ Conv T cells, Helios+ Conv T cells and Ki67+ Conv T cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Percentage of leukocyte subsets including CD15s+ Memory Conv T cells, CD69+ Memory Conv T cells, Helios+ Memory Conv T cells and Ki67+ Memory Conv T cells in iLN core biopsies and iLN FNA
    Timeframe: Biopsy session on Day 1

  • Number of participants with serious adverse events (SAEs) and non-SAEs
    Timeframe: Up to Day 14

  • Number of participants undergoing procedure under local anesthetics
    Timeframe: Up to Day 4

  • Number of participants undergoing iLN biopsy under local anesthetics
    Timeframe: Up to Day 4

  • Number of participants with different reasons for participating in the study
    Timeframe: Up to Day 4

  • Number of participants with extreme anxiety towards the lymph node biopsy
    Timeframe: Up to Day 4

  • Number of participants looking forward to undergo the procedure
    Timeframe: Up to Day 4

  • Number of participants with aspects better explained about the lymph node biopsy procedure
    Timeframe: Up to Day 4

  • Number of participants who considered to undergo lymph node biopsy procedure another time
    Timeframe: Up to Day 4

  • Number of participants who were encouraged to be included in study for iLN biopsy
    Timeframe: Up to Day 4

  • Number of participants who appreciated receiving study feedback
    Timeframe: Up to Day 4

Arms:
  • 2

Interventions:

  • Procedure/Surgery: Inguinal lymph node fine needle aspirate biopsy
  • Procedure/Surgery: Inguinal lymph node core biopsy
  • Procedure/Surgery: Peripheral blood collection
  • Other: Pre- and post-biopsy questionnaire

Keyword:

  • Biomarker, Immune Profile, Biopsy, Leukocyte subsets, Inguinal lymph nodes, Type 1 Diabetes Mellitus
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 22