Chemoresistance and Involvement of the NOTCH Pathway in Patients With Lung Adenocarcinoma

NCT02898857 | Unknown DMC

• 1 other identifier: 9758
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Every year in France, 30.000 deaths are due to lung cancer and 39.500 new cases of this disease are diagnosed (INCa 2014). Patients suffering from locally advanced non-small-cell lung cancer (NSCLC), stage IIIa, usually undergo a multimodality treatment including chemotherapy with platinum compounds before surgery (called neoadjuvant chemotherapy or induction chemotherapy). The reason of this combined modality treatment is the really poor prognosis of patients presenting a disease already spread to lymph nodes (classified N2 when the lymph node under the carina is affected). Up till now, the five-year survival of patients who underwent surgical resection of N2 NSCLC does not exceed 15%

Conditions

Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• analysed by immunochemistry (IHC)

  The biopsies of lung tumour samples will be analysed by immunochemistry (IHC)

  1 day

Secondary Outcomes (2)

• western blotting (WB)

  1 day

• qPolymerase Chain Reaction (PCR)

  1 day

Study Arms (3)

down-staging of a KRAS

Six with demonstrated down-staging of a KRAS mutant adenocarcinoma who underwent biopsie The biopsies of lung tumour samples will be analysed by immunochemistry (IHC), western blotting and qPolymerase Chain Reaction (PCR) approaches

Other: biopsies

no down-staging of a KRAS

Six with demonstrated no down-staging (persistent tumour cell involving lymph nodes in surgically resected specimens) of a KRAS mutant adenocarcinoma who underwent biopsie The biopsies of lung tumour samples will be analysed by immunochemistry (IHC), western blotting and qPolymerase Chain Reaction (PCR) approaches

Other: biopsies

non-staging and triple negative adenocarcinoma

Six with or without non-staging and triple negative adenocarcinoma who underwent biopsie The biopsies of lung tumour samples will be analysed by immunochemistry (IHC), western blotting and qPolymerase Chain Reaction (PCR) approaches

Other: biopsies

Interventions

biopsies OTHER

The biopsies of lung tumour samples will be analysed by immunochemistry (IHC), western blotting and qPolymerase Chain Reaction (PCR) approaches in Six with demonstrated down-staging of a KRAS mutant adenocarcinoma, Six with demonstrated no down-staging (persistent tumour cell involving lymph nodes in surgically resected specimens) of a KRAS mutant adenocarcinoma and Six with or without non-staging and triple negative adenocarcinoma

down-staging of a KRAS; no down-staging of a KRAS; non-staging and triple negative adenocarcinoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Six with demonstrated down-staging of a KRAS mutant adenocarcinoma * Six with demonstrated no down-staging (persistent tumour cell involving lymph nodes in surgically resected specimens) of a KRAS mutant adenocarcinoma * Six with or without non-staging and triple negative adenocarcinoma

You may qualify if:

• patients of both sex, aged 75 years or younger, diagnostic specimen demonstrating an adenocarcinoma, KRAS mutation on exon 2 and codon 12 or codon 13 or triple negative, clinical pathological N2, having received a platinum-based regimen as first line therapy, at less three courses of chemotherapy must have been delivered, with only these molecules : cisplatin-vinorelbine, cisplatin-gemcitabine, cisplatin-docetaxel, cisplatin-paclitaxel, having been operated upon and having been surgically resected R0 or R1.

You may not qualify if:

• patients having received more than one line of preoperative chemotherapy, having received concurrent chemo-radiotherapy as preoperative treatment, no available diagnostic specimen, patients who underwent R2 resection or no resection, patients affected by adenocarcinoma harbouring either EGFR mutation or EML4-ALK translocation, patients with pathological complete response (yT0yN0).

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut de Recherche en Cancérologie de Montpellier (IRCM): collaborator

Study Sites (1)

PUJOL

Montpellier, Montpellier, 34290, France

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean Louis PUJOL, MD, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Jean Louis PUJOL, MD, PhD

CONTACT

4 67 33 61 35; jl-pujol@chu-montpellier.fr

Camille TRAVERT

CONTACT

4 67 33 61 35; jl-pujol@chu-montpellier.fr

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 13, 2016

Record last verified: 2016-08

Locations

FR (1)