NCT00220077

Brief Summary

Knowledge of the impact of gene expression profiling could allow optimisation of chemotherapy regimens for individual patients. It could ensure that patients do not receive a particular form of chemotherapy if it is unlikely to benefit them, and in these circumstances an alternative form of chemotherapy that may prove beneficial could be selected. This information will therefore allow chemotherapy to be tailored to the individual tumour. It may help identify those patients with a poorer prognosis who could be selected for further therapy post surgery or a different treatment strategy at the outset.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

First QC Date

September 19, 2005

Last Update Submit

November 23, 2015

Conditions

Oesophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • To determine whether specific gene expression profiles are associated with response in oesophago-gastric cancer.

Secondary Outcomes (1)

  • Evaluation of the association of gene expression profiling and progression free survival and overall survival in patients with oesophago-gastric cancer.

Interventions

EndoscopyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient with histologically proven operable ,locally advanced and metastatic oesophageal or gastric carcinoma.

You may not qualify if:

  • Second malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • David Cunningham

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheela Rao

CONTACT

0208 642 6011sheela.rao@rmh.nhs.uk

Naureen Starling

CONTACT

0208 642 6011naureen.starling@rmh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

June 1, 2002

Last Updated

November 25, 2015

Record last verified: 2015-11

Locations

GB(1)