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Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project (IMPACT)

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ClinicalTrials.gov Identifier: NCT02806388
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Brief Summary:
This study aims to screen tumor molecular profile for better selection of anticancer treatment, in particular, allocation to clinical trials if available.

Condition or disease
Solid Tumor

Detailed Description:
Molecular profiling will be performed on archival tumor tissue or freshly collected tumor tissue from re-biopsy. Blood and/or saliva may be collected to study the genetic makeup and also to compare the tumor molecular profile. Personalized therapy will be given based on molecular profile.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Individualized Molecular Profiling for Allocation to Clinical Trials (IMPACT) Project
Study Start Date : October 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort
tumor tissue for molecular profiling



Primary Outcome Measures :
  1. The molecular and clinical epidemiology for cancer patients being considered for novel therapeutics [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. The proportion of patients who have actionable alterations and enrol into clinical trials [ Time Frame: 5 years ]
  2. The correlation of molecular profiles with clinical outcomes [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Remaining tumor and/or blood and/or saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any advanced cancer patient who would benefit from molecular profiling and is a potential clinical trial candidate as identified by treating physician.
Criteria

Inclusion Criteria:

  • Confirmed histological diagnosis of solid tumor
  • Suitable for systematic treatment and clinical trials
  • ECOG (Eastern cooperative oncology group) performance status < 2
  • Able to provide tumor tissue for molecular profiling
  • Able to understand and sign the informed consent form

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806388


Contacts
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Contact: Daniel SW Tan +65 6436 8000 daniel.tan.s.w@singhealth.com.sg

Locations
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Singapore
National Cancer Centre singapore Recruiting
Singapore, Singapore
Sponsors and Collaborators
National Cancer Centre, Singapore
Investigators
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Principal Investigator: Daniel SW Tan National Cancer Centre, Singapore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT02806388     History of Changes
Other Study ID Numbers: ECRU-IMPACT
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No