Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer

NCT ID: NCT00864266

Last Updated: 2020-06-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2020-06-30

Brief Summary

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The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.

Detailed Description

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Conditions

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Non Small Cell Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

After obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org)

Group Type EXPERIMENTAL

Chemotherapy

Intervention Type DRUG

Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)

Interventions

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Chemotherapy

Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological diagnosis of non-small-cell lung cancer (NSCLC)
* Obtention of a biopsy of the tumour according to the procedure defined in the protocol
* NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as defined in the ELCWP guidelines (www.elcwp.org)
* Presence of at least one assessable lesion
* Availability for participating in the detailed follow-up of the protocol
* Signed informed consent.
* Age above 18 years

Exclusion Criteria

* Patient who was previously treated with chemotherapy for NSCLC or who has any contra-indication precluding the administration of conventional chemotherapy for NSCLC
* NSCLC treated by exclusive surgery or radiotherapy
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Lung Cancer Working Party

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Berghmans, MD

Role: STUDY_CHAIR

European Lung Cancer Working Party

Locations

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Department of Pneumology Clinique Saint-Luc

Bouge, , Belgium

Site Status

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, , Belgium

Site Status

Service de Pneumologie Hôpital Erasme

Brussels, , Belgium

Site Status

Department of Pneumology Hôpital Saint-Joseph

Gilly, , Belgium

Site Status

Hôpital Ambroise Paré

Mons, , Belgium

Site Status

Department of Pneumology Centre Hospitalier de Mouscron

Mouscron, , Belgium

Site Status

Countries

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Belgium

References

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Berghmans T, Ameye L, Lafitte JJ, Colinet B, Cortot A, CsToth I, Holbrechts S, Lecomte J, Mascaux C, Meert AP, Paesmans M, Richez M, Scherpereel A, Tulippe C, Willems L, Dernies T, Leclercq N, Sculier JP; European Lung Cancer Working Party. Prospective Validation Obtained in a Similar Group of Patients and with Similar High Throughput Biological Tests Failed to Confirm Signatures for Prediction of Response to Chemotherapy and Survival in Advanced NSCLC: A Prospective Study from the European Lung Cancer Working Party. Front Oncol. 2015 Jan 28;4:386. doi: 10.3389/fonc.2014.00386. eCollection 2014.

Reference Type DERIVED
PMID: 25674536 (View on PubMed)

Berghmans T, Ameye L, Willems L, Paesmans M, Mascaux C, Lafitte JJ, Meert AP, Scherpereel A, Cortot AB, Cstoth I, Dernies T, Toussaint L, Leclercq N, Sculier JP; European Lung Cancer Working Party. Identification of microRNA-based signatures for response and survival for non-small cell lung cancer treated with cisplatin-vinorelbine A ELCWP prospective study. Lung Cancer. 2013 Nov;82(2):340-5. doi: 10.1016/j.lungcan.2013.07.020. Epub 2013 Aug 7.

Reference Type DERIVED
PMID: 24007627 (View on PubMed)

Related Links

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http://www.elcwp.org

(Click here for more information on the protocol)

Other Identifiers

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01082

Identifier Type: -

Identifier Source: org_study_id

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