Integrated Molecular Analysis of Cancer (IMAC)

NCT02078544 | Unknown

• 1 other identifier: 2013/00705 ; 2014/00131
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to identify biomarkers and potentially actionable mutations/ activated molecular pathways and evaluate the impact of molecular profiling information on patients with cancer. The hypothesis of the study are:

• Analysis of tumour samples will allow us to identify novel and/or actionable molecular changes that may drive therapeutic strategies for the management of cancers.
• Molecular profiling will improve the outcome of novel targeted-agent treatment in clinical trials
• Molecular profiling of paired samples (primary/recurrent and primary/metastatic) will provide new insights into mechanisms underlying drug resistance and metastasis in cancers.

Conditions

Cancer

Keywords

Oncology

Outcome Measures

Primary Outcomes (3)

• 1. Characterization of identified biomarkers and potentially actionable mutations/ activated molecular pathways

  By identifying biomarkers and actionable mutations/molecular pathways in patients and characterizing them, we can evaluate the impact of molecular profiling information on patients with cancer. The spectrum and development of molecularly targeted agents is rapidly expanding, and it is increasingly likely that the future of cancer management will require the molecular and histological subtype of one's tumor to be defined in order to decide on the most appropriate treatment strategy.

  2 years

• To compare progression free survival (PFS) on matched therapy vs non-matched therapy in cancer patients enrolled into molecular targeted therapy/ biomarker-driven clinical trials.

  Progression free survival (PFS) on matched targeted therapy based on molecular profiling compared with PFS on previous non-targeted therapy will be compared to assess the clinical impact of molecular profiling in these patients.

  2 years

• To compare overall response rates (ORR) on matched therapy vs non-matched therapy in cancer patients enrolled into molecular targeted therapy/ biomarker-driven clinical trials.

  Overall response rates (ORR) on matched targeted therapy based on molecular profiling versus non-matched therapy will be compared to assess the clinical impact of molecular profiling in these patients.

  2 years

Study Arms (1)

All cancer

Other: Integrated Molecular Analysis

Interventions

Integrated Molecular Analysis OTHER

All cancer

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated with cancers at National University Hospital.

You may qualify if:

• Patients with histological confirmation of cancers who are candidates for systemic therapy, including molecular-targeted therapy/ biomarker-driven clinical trials.
• Patients must be ≥ 21 years old.
• All patients must have signed and dated an informed consent form.
• All patients must have sufficient tumour tissue for molecular profiling

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

David Tan Shao Peng

Singapore, 119074, Singapore

RECRUITING

Related Publications (2)

• Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov. 2004 Aug;3(8):711-5. doi: 10.1038/nrd1470. No abstract available.

  PMID: 15286737 BACKGROUND

• Stewart DJ, Kurzrock R. Cancer: the road to Amiens. J Clin Oncol. 2009 Jan 20;27(3):328-33. doi: 10.1200/JCO.2008.18.9621. Epub 2008 Dec 8. No abstract available.

  PMID: 19064964 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

I. Tumour samples from patients with a diagnosis of cancer from year 1995 to 31 July 2013 will be obtained from the pathology archives and tissue repository. II. Blood, tumour and ascitic and pleural fluid samples will be prospectively collected.

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Shao peng David Tan, MBBS, MRCP, PHD

CONTACT

(65) 6779 5555; david_sp_tan@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: March 5, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-09

Locations

SG (1)