Malignant LymphomaNCT01789060
p-AKT Expression on Clinical Outcomes in Malignant Lymphoma
An observational study of Malignant Lymphoma and P13K-AKT Pathway Deregulation, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 90 years
- Conditions the study is for
- Malignant Lymphoma, P13K-AKT Pathway Deregulation
- What is being tested?
- p-AKT immunohistochemical staining
- How many people
- 262 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Feb 2013
- 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 17 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with malignant lymphoma who are treated in a tertiary hospital in Korea (Samsung Medical Center)
Who may be able to join
- 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.
Who cannot join
- 1. Primary central nervous system lymphoma was excluded in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Activated p-AKT Expression on Clinical Outcomes in Malignant Lymphoma : A Clinicopathological Study
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.
Read the detailed description
Recently, among diverse oncogenic signaling pathways, a number of studies have focused on the significance of oncogenic PI3K/AKT (phophatidylinositol 3-kinase/serine-threonine kinase, also known as protein kinase B [PKB]) pathway. PI3K(phosphatidylinositol 3-kinase)/AKT pathway phosphorylates and activates AKT as phosphorylated AKT (p-AKT) and plays a critical role promoting malignant phenotype and has prognostic significance in various solid cancers.
However, a systematic approach on the impact of p-AKT overexpression on clinical outcomes has not been performed in malignant lymphoma.
- Conditions
- Malignant Lymphoma, P13K-AKT Pathway Deregulation
- Being tested
- p-AKT immunohistochemical staining
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
p-AKT immunohistochemical stainingOther
p-AKT staining on the adequate paraffin-embedded biopsy specimen or unstained slides
| Study group | Role | What they receive |
|---|---|---|
| p-AKT | p-AKT immunohistochemical staining,high p-AKT expression (upper quartile), low p-AKT expression (lower 3 quartiles) Receives: Other: p-AKT immunohistochemical staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of overall survival according to p-AKT status in malignant lymphoma
Measured: study entry
Secondary outcomes (1)
Subgroup analysis of overall survival according to histologic subtypes (GCB vs non GCB)
Measured: study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Won Seog Kim, MD PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789060
- Sponsor's protocol ID
- 2013-01-047
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24356628
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Activated p-AKT Expression on Clinical Outcomes in Malignant Lymphoma : A Clinicopathological Study
- ClinicalTrials.gov ID
- NCT01789060
- Acronym / sponsor ID
- 2013-01-047
- Conditions
- Malignant Lymphoma, P13K-AKT Pathway Deregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Feb 2013 (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.
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.
Detailed description
Recently, among diverse oncogenic signaling pathways, a number of studies have focused on the significance of oncogenic PI3K/AKT (phophatidylinositol 3-kinase/serine-threonine kinase, also known as protein kinase B [PKB]) pathway. PI3K(phosphatidylinositol 3-kinase)/AKT pathway phosphorylates and activates AKT as phosphorylated AKT (p-AKT) and plays a critical role promoting malignant phenotype and has prognostic significance in various solid cancers.
However, a systematic approach on the impact of p-AKT overexpression on clinical outcomes has not been performed in malignant lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| p-AKT | – | Other: p-AKT immunohistochemical stainingp-AKT immunohistochemical staining,high p-AKT expression (upper quartile), low p-AKT expression (lower 3 quartiles) |
Who may qualify
- Ages
- 17 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with malignant lymphoma who are treated in a tertiary hospital in Korea (Samsung Medical Center)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Primary central nervous system lymphoma was excluded in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| p-AKT immunohistochemical stainingp-AKT staining on the adequate paraffin-embedded biopsy specimen or unstained slides | Other | p-AKT |
Primary outcome
Difference of overall survival according to p-AKT status in malignant lymphoma
Time frame: study entry
1 secondary outcome
Subgroup analysis of overall survival according to histologic subtypes (GCB vs non GCB)
Time frame: study entry
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 11 Feb 2013.
- Derived from this study: PubMed 24356628Hong 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.
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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.
Won Seog Kim, MD PhD principal investigator
Samsung Medical Center
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 Malignant Lymphoma and P13K-AKT Pathway Deregulation, run by Samsung Medical Center at 1 site in South Korea.
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 2 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 11 Feb 2013. 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 South Korea. 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?
Difference of overall survival according to p-AKT status in malignant lymphoma (time frame: study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01789060, which also lists 1 linked publication.
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 11 Feb 2013.