NCT02112357

Brief Summary

This study will assess the feasibility of sequencing locally advanced/metastatic gastrointestinal cancers in real-time to enable future treatment stratification by molecular characteristics. Targeted next generation sequencing of a panel of genes will be performed on tumour specimens and results will be discussed at a Sequencing Tumour Board to establish if a patient is potentially suitable for a targeted therapy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

1.5 years

First QC Date

March 31, 2014

Last Update Submit

April 16, 2014

Conditions

Advanced Gastrointestinal Cancers

Keywords

molecular profilinggenetic sequencingpersonalised medicinegastrointestinal cancer

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients in whom a currently actionable molecular alteration was detected by genetic sequencing.

    18 months

Secondary Outcomes (7)

  • The concordance of results obtained from genetic sequencing compared to standard clinically validated techniques.

    18 months

  • The proportion of patients in whom genetic sequencing was successfully performed.

    18 months

  • The percentage of patients with a currently actionable genetic alteration who received targeted therapy as a result of genetic sequencing.

    18 months

  • Evaluation of the time required to obtain genetic sequencing results to see if genetic sequencing could be practically incorporated into clinical practice.

    18 months

  • The proportion of screened patients who decide to participate in the trial and their reasons for participation or deciding not to participate.

    18 months

  • +2 more secondary outcomes

Other Outcomes (6)

  • Response rate for patients who received a targeted treatment as a result of genetic sequencing.

    18 months

  • Overall survival of patients who received targeted treatment.

    18 months

  • Evaluation of any changes in molecular markers at the time of disease progression or response to those from previous specimens.

    18 months

  • +3 more other outcomes

Study Arms (1)

Targeted genetic sequencing of tumour specimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Locally advanced or metastatic gastrointestinal cancer (including gastroesophageal, pancreatic, biliary tract and colorectal cancer)

You may qualify if:

  • Locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers).
  • Histological or cytological confirmation of diagnosis of malignancy.
  • Patients must either:
  • Have received at least one line of treatment for locally advanced/metastatic disease OR
  • Be about to start/currently undergoing their first line of treatment for locally advanced/metastatic disease
  • years of age and over .
  • Performance status less than or equal to 2.
  • Able to provide fully informed consent.
  • Patients must either:
  • Have an available tumour specimen (FFPE or fresh frozen) from either the primary tumour or a metastasis. Metastatic samples may be from any site with the exception of bone. OR
  • Have a site of disease which is amendable to biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London and Surrey, SM 25PT, United Kingdom

RECRUITING

Related Publications (2)

  • Mansukhani S, Barber LJ, Kleftogiannis D, Moorcraft SY, Davidson M, Woolston A, Proszek PZ, Griffiths B, Fenwick K, Herman B, Matthews N, O'Leary B, Hulkki S, Gonzalez De Castro D, Patel A, Wotherspoon A, Okachi A, Rana I, Begum R, Davies MN, Powles T, von Loga K, Hubank M, Turner N, Watkins D, Chau I, Cunningham D, Lise S, Starling N, Gerlinger M. Ultra-Sensitive Mutation Detection and Genome-Wide DNA Copy Number Reconstruction by Error-Corrected Circulating Tumor DNA Sequencing. Clin Chem. 2018 Nov;64(11):1626-1635. doi: 10.1373/clinchem.2018.289629. Epub 2018 Aug 27.

    PMID: 30150316DERIVED

  • Moorcraft SY, Gonzalez de Castro D, Cunningham D, Jones T, Walker BA, Peckitt C, Yuan LC, Frampton M, Begum R, Eltahir Z, Wotherspoon A, Teixeira Mendes LS, Hulkki Wilson S, Gillbanks A, Baratelli C, Fotiadis N, Patel A, Braconi C, Valeri N, Gerlinger M, Rao S, Watkins D, Chau I, Starling N. Investigating the feasibility of tumour molecular profiling in gastrointestinal malignancies in routine clinical practice. Ann Oncol. 2018 Jan 1;29(1):230-236. doi: 10.1093/annonc/mdx631.

    PMID: 29361134DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Both fresh frozen tissue and formalin-fixed paraffin-embedded (FFPE) tumour samples will be obtained. Biopsies may be taken at entry to the study and/or at the time of radiological response assessment. Each patient can have a maximum of 3 research biopsies in this study. Up to 35 ml of blood will be collected at study entry to provide normal germline DNA and for possible additional biomarker analysis. If the patient has consented to optional blood sample collection, then additional blood samples will also be collected at the time of radiological response assessment to study molecular changes that occur during treatment.

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Dr. Naureen Starling, BSc, MBBS, MRCP

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Naureen Starling, BSc, MBBS, MRCP

CONTACT

+44 (0)208 661 3156naureen.starling@rmh.nhs.uk

Annie Woodburne, BSc, MSc

CONTACT

+44 (0)208 661 3807annie.woodburne@rmh.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 11, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2015

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

GB(1)