NCT01789060

Brief Summary

PI3K(phosphatidylinositol 3-kinase)/AKT pathway is an important oncogenic signaling pathway. However, clinical information about the significance of p-AKT expression in malignant lymphoma is not fully understood yet. In this study, we investigated the overexpression of p-AKT and its prognostic implication in malignant lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

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

December 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

2 months

First QC Date

February 7, 2013

Last Update Submit

February 7, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference of overall survival according to p-AKT status in malignant lymphoma

    study entry

Secondary Outcomes (1)

  • Subgroup analysis of overall survival according to histologic subtypes (GCB vs non GCB)

    study entry

Other Outcomes (1)

  • Subgroup analysis of overall survival according to International Prognostic Index risk groups

    study entry

Study Arms (1)

p-AKT

p-AKT immunohistochemical staining,high p-AKT expression (upper quartile), low p-AKT expression (lower 3 quartiles)

Other: p-AKT immunohistochemical staining

Interventions

p-AKT staining on the adequate paraffin-embedded biopsy specimen or unstained slides

p-AKT

Eligibility Criteria

Age17 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with malignant lymphoma who are treated in a tertiary hospital in Korea (Samsung Medical Center)

You may qualify if:

  • the patients were pathologically confirmed of malignant lymphoma, according to the World Health Organization classification;
  • the patients had adequate paraffin-embedded biopsy specimen or unstained slides for immunostaining of p-AKT.

You may not qualify if:

  • \. Primary central nervous system lymphoma was excluded in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Hong JY, Hong ME, Choi MK, Kim YS, Chang W, Maeng CH, Park S, Lee SJ, Do IG, Jo JS, Jung SH, Kim SJ, Ko YH, Kim WS. The impact of activated p-AKT expression on clinical outcomes in diffuse large B-cell lymphoma: a clinicopathological study of 262 cases. Ann Oncol. 2014 Jan;25(1):182-8. doi: 10.1093/annonc/mdt530.

Biospecimen

Retention: SAMPLES WITHOUT DNA

paraffin-embedded biopsy specimen or unstained slides for immunostaining of p-AKT

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Won Seog Kim, MD PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

December 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations