NCT02155621

Brief Summary

The genomic heterogeneity of cancers implies that to effectively use targeted therapies the investigators will need to assess each individual cancer and match it to a biologically relevant targeted therapy. The investigators will use full genome sequencing to try to identify cancer "drivers" and corresponding drugs that may inhibit these pathways.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

June 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

11.7 years

First QC Date

June 2, 2014

Last Update Submit

September 17, 2025

Conditions

Keywords

cancer genomicsprecision medicinemetastatic cancerclinical decision-making

Outcome Measures

Primary Outcomes (2)

  • Influence of genomic data on clinical decision-making

    This outcome will allow us to study how often in-depth genomic data impacts on clinical decision-making in a general oncology population. It will help describe how useful or important this sort of data is in daily practice.

    5 years

  • Cataloging of cancer genomes

    Accumulation of genomic information linked to treatment/outcome data will greatly enhance our knowledge and understanding of cancers and response to treatment.

    5 years

Study Arms (1)

Genome Sequencing

EXPERIMENTAL

There is only one arm to this study.

Genetic: Genome sequencing

Interventions

Subjects will have their cancers biopsied and blood samples taken; both will undergo genomic sequencing and analysis

Genome Sequencing

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must agree to allow their archival specimens to be used and possibly completely depleted for these analyses.
  • Willing and able to have a study-specific biopsy or resection of the tumour or metastatic site OR if there is adequate archival material available, either fresh frozen or FFPE (if specimen is thought to be adequate) that is taken after the most recent chemo or radiation. Ideally this sample should have been collected within 16 weeks of the date of consent. If archival tissue is not adequate and if a biopsy is not feasible or deemed medically safe by the investigators the patient would become ineligible.
  • Patients must understand and agree to provide a blood test (or other sample of normal DNA) for germline genomic analysis.
  • ECOG PS 0 or 1.
  • Age \>/= 18 years.
  • Estimated life expectancy \>/= 6 months and high likelihood of being clinically fit for a therapeutic clinical trial in 3-6 months.
  • Measurable disease with RECIST v1.1 (or updated version).
  • Adequate organ function.
  • Patients must clearly understand that this data may be used to help guide treatment recommendations, including the avoidance of some therapeutic agents or the suggestion to use standard cytotoxic chemotherapy agents.
  • Willingness to have their de-identified genomic and clinical data shared with national and international research collaborators and data sharing platforms (as detailed in the consent form).
  • Willingness to be contacted for future studies based on the data that is generated by participation in POG; included in this is the anticipation that patient would be fit or a candidate for clinical trials.

You may not qualify if:

  • Unable or unwilling to consent to the above tissue and blood requirements.
  • Significant medical condition that in the opinion of the treating or consenting oncologist and/or the POG central office review team renders the subject not suitable for participation. This includes the likelihood that a subject would be suitable for a clinical trial within 12 weeks after POG biopsy.
  • Unwilling or unable to provide treatment and outcome follow up information to the BC Cancer or affiliated investigators.
  • Unwilling to receive medically actionable findings (germline and/or somatic).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Related Publications (12)

  • Jamshidi F, Pleasance E, Li Y, Shen Y, Kasaian K, Corbett R, Eirew P, Lum A, Pandoh P, Zhao Y, Schein JE, Moore RA, Rassekh R, Huntsman DG, Knowling M, Lim H, Renouf DJ, Jones SJ, Marra MA, Nielsen TO, Laskin J, Yip S. Diagnostic value of next-generation sequencing in an unusual sphenoid tumor. Oncologist. 2014 Jun;19(6):623-30. doi: 10.1634/theoncologist.2013-0390. Epub 2014 May 7.

    PMID: 24807916BACKGROUND
  • Jones SJ, Laskin J, Li YY, Griffith OL, An J, Bilenky M, Butterfield YS, Cezard T, Chuah E, Corbett R, Fejes AP, Griffith M, Yee J, Martin M, Mayo M, Melnyk N, Morin RD, Pugh TJ, Severson T, Shah SP, Sutcliffe M, Tam A, Terry J, Thiessen N, Thomson T, Varhol R, Zeng T, Zhao Y, Moore RA, Huntsman DG, Birol I, Hirst M, Holt RA, Marra MA. Evolution of an adenocarcinoma in response to selection by targeted kinase inhibitors. Genome Biol. 2010;11(8):R82. doi: 10.1186/gb-2010-11-8-r82. Epub 2010 Aug 9.

    PMID: 20696054BACKGROUND
  • Laskin J, Jones S, Aparicio S, Chia S, Ch'ng C, Deyell R, Eirew P, Fok A, Gelmon K, Ho C, Huntsman D, Jones M, Kasaian K, Karsan A, Leelakumari S, Li Y, Lim H, Ma Y, Mar C, Martin M, Moore R, Mungall A, Mungall K, Pleasance E, Rassekh SR, Renouf D, Shen Y, Schein J, Schrader K, Sun S, Tinker A, Zhao E, Yip S, Marra MA. Lessons learned from the application of whole-genome analysis to the treatment of patients with advanced cancers. Cold Spring Harb Mol Case Stud. 2015 Oct;1(1):a000570. doi: 10.1101/mcs.a000570.

    PMID: 27148575BACKGROUND
  • Skamene T, Siu LL, Renouf DJ, Laskin JJ, Bedard PL, Jones SJM, Ferrario C, Whitlock J, Petrie J, Sullivan P, Malone ER, Nomikos D, Chen BE, Dancey Y. Canadian profiling and targeted agent utilization trial (CAPTUR/PM.1): A phase II basket precision medicine trial. J Clin Oncol. 2018;36(15), TPS12127. doi:10.1200/JCO.2018.36.15_suppl.TPS12127

    BACKGROUND
  • Yu IS, Wee K, Williamson L, Titmuss E, An J, Naderi-Azad S, Metcalf C, Yip S, Horst B, Jones SJM, Paton K, Nelson BH, Marra M, Laskin JJ, Savage KJ. Exceptional response to combination ipilimumab and nivolumab in metastatic uveal melanoma: Insights from genomic analysis. Melanoma Res. 2022 Aug 1;32(4):278-285. doi: 10.1097/CMR.0000000000000810. Epub 2022 Jun 17.

  • Lavoie JM, Mitchell T, Lee SE, Deol B, Chia SK, Gelmon KA, Kollmannsberger CK, Tinker AV, Jones SJM, Marra M, Laskin J, Renouf DJ. Patient selection for a developmental therapeutics program using whole genome and Transcriptome analysis. Invest New Drugs. 2020 Oct;38(5):1601-1604. doi: 10.1007/s10637-020-00892-8. Epub 2020 Jan 6.

  • Karasinska JM, Topham JT, Kalloger SE, Jang GH, Denroche RE, Culibrk L, Williamson LM, Wong HL, Lee MKC, O'Kane GM, Moore RA, Mungall AJ, Moore MJ, Warren C, Metcalfe A, Notta F, Knox JJ, Gallinger S, Laskin J, Marra MA, Jones SJM, Renouf DJ, Schaeffer DF. Altered Gene Expression along the Glycolysis-Cholesterol Synthesis Axis Is Associated with Outcome in Pancreatic Cancer. Clin Cancer Res. 2020 Jan 1;26(1):135-146. doi: 10.1158/1078-0432.CCR-19-1543. Epub 2019 Sep 3.

  • Wong D, Shen Y, Levine AB, Pleasance E, Jones M, Mungall K, Thiessen B, Toyota B, Laskin J, Jones SJM, Marra MA, Yip S. The pivotal role of sampling recurrent tumors in the precision care of patients with tumors of the central nervous system. Cold Spring Harb Mol Case Stud. 2019 Aug 1;5(4):a004143. doi: 10.1101/mcs.a004143. Print 2019 Aug.

  • Williamson LM, Steel M, Grewal JK, Thibodeau ML, Zhao EY, Loree JM, Yang KC, Gorski SM, Mungall AJ, Mungall KL, Moore RA, Marra MA, Laskin J, Renouf DJ, Schaeffer DF, Jones SJM. Genomic characterization of a well-differentiated grade 3 pancreatic neuroendocrine tumor. Cold Spring Harb Mol Case Stud. 2019 Jun 3;5(3):a003814. doi: 10.1101/mcs.a003814. Print 2019 Jun.

  • Thibodeau ML, Zhao EY, Reisle C, Ch'ng C, Wong HL, Shen Y, Jones MR, Lim HJ, Young S, Cremin C, Pleasance E, Zhang W, Holt R, Eirew P, Karasinska J, Kalloger SE, Taylor G, Majounie E, Bonakdar M, Zong Z, Bleile D, Chiu R, Birol I, Gelmon K, Lohrisch C, Mungall KL, Mungall AJ, Moore R, Ma YP, Fok A, Yip S, Karsan A, Huntsman D, Schaeffer DF, Laskin J, Marra MA, Renouf DJ, Jones SJM, Schrader KA. Base excision repair deficiency signatures implicate germline and somatic MUTYH aberrations in pancreatic ductal adenocarcinoma and breast cancer oncogenesis. Cold Spring Harb Mol Case Stud. 2019 Apr 1;5(2):a003681. doi: 10.1101/mcs.a003681. Print 2019 Apr.

  • Wong HL, Yang KC, Shen Y, Zhao EY, Loree JM, Kennecke HF, Kalloger SE, Karasinska JM, Lim HJ, Mungall AJ, Feng X, Davies JM, Schrader K, Zhou C, Karsan A, Jones SJM, Laskin J, Marra MA, Schaeffer DF, Gorski SM, Renouf DJ. Molecular characterization of metastatic pancreatic neuroendocrine tumors (PNETs) using whole-genome and transcriptome sequencing. Cold Spring Harb Mol Case Stud. 2018 Feb 1;4(1):a002329. doi: 10.1101/mcs.a002329. Print 2018 Feb.

  • Jones MR, Lim H, Shen Y, Pleasance E, Ch'ng C, Reisle C, Leelakumari S, Zhao C, Yip S, Ho J, Zhong E, Ng T, Ionescu D, Schaeffer DF, Mungall AJ, Mungall KL, Zhao Y, Moore RA, Ma Y, Chia S, Ho C, Renouf DJ, Gelmon K, Jones SJM, Marra MA, Laskin J. Successful targeting of the NRG1 pathway indicates novel treatment strategy for metastatic cancer. Ann Oncol. 2017 Dec 1;28(12):3092-3097. doi: 10.1093/annonc/mdx523.

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Janessa J Laskin, MD

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janessa J Laskin, MD

CONTACT

Marco Marra, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 4, 2014

Study Start

July 1, 2014

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations