NCT01130584

Brief Summary

The purpose of this study is to determine if pyruvate kinase M2 (PKM2) can be used as a biomarker in cancer. Pyruvate kinase M2 is more elevated in malignant pleural fluid than in plasma, and may be a useful biomarker to distinguish between malignant and non-malignant causes of pleural effusion. In addition, pyruvate kinase M2 has also been found to be elevated in saliva in cancer patients compared to controls. Measuring pyruvate kinase M2 in saliva may be used to diagnose cancer or monitor the treatment progress of cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2010

Typical duration 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

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

3 years

First QC Date

May 24, 2010

Last Update Submit

December 10, 2013

Conditions

Keywords

Cancer Patients

Study Arms (1)

Cancer patient

Other: Pyruvate kinase isoform M2

Interventions

Cancer patient

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any cancer patient

You may qualify if:

  • Any cancer patient with pleural effusion that is being drained through an indwelling chest-tube in an inpatient ward.

You may not qualify if:

  • Patient with a pleural effusion who does not have proven cancer or whose pleural effusion is not known to be malignant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital, Singapore

Singapore, Singapore

Location

Related Publications (2)

  • Elia S, Massoud R, Guggino G, Cristino B, Cortese C, De Massimi AR, Zenobi R. Tumor type M2-pyruvate-kinase levels in pleural fluid versus plasma in cancer patients: a further tool to define the need for invasive procedures. Eur J Cardiothorac Surg. 2008 Apr;33(4):723-7. doi: 10.1016/j.ejcts.2008.01.014. Epub 2008 Feb 7.

    PMID: 18261916BACKGROUND
  • Mazurek S. Pyruvate kinase type M2: a key regulator within the tumour metabolome and a tool for metabolic profiling of tumours. Ernst Schering Found Symp Proc. 2007;(4):99-124. doi: 10.1007/2789_2008_091.

    PMID: 18811055BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 26, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations