Feasibility of a Molecular Characterisation Approach to Treatment

NCT ID: NCT02112357

Last Updated: 2014-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Gastrointestinal Cancers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Targeted genetic sequencing of tumour specimen

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers).
2. Histological or cytological confirmation of diagnosis of malignancy.
3. Patients must either:

1. Have received at least one line of treatment for locally advanced/metastatic disease OR
2. Be about to start/currently undergoing their first line of treatment for locally advanced/metastatic disease
4. 18 years of age and over .
5. Performance status less than or equal to 2.
6. Able to provide fully informed consent.
7. Patients must either:

1. 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
2. Have a site of disease which is amendable to biopsy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Naureen Starling, BSc, MBBS, MRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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The Royal Marsden NHS Foundation Trust

London and Surrey, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dr. Naureen Starling, BSc, MBBS, MRCP

Role: CONTACT

+44 (0)208 661 3156

Annie Woodburne, BSc, MSc

Role: CONTACT

+44 (0)208 661 3807

Facility Contacts

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Annie Woodburne, MSc, BSc

Role: primary

+44 (0)208 661 3807

References

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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.

Reference Type DERIVED
PMID: 30150316 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29361134 (View on PubMed)

Other Identifiers

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CCR 3994

Identifier Type: -

Identifier Source: org_study_id

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