NCT04677205 Molecular Signature From Tumor to Lymph Nodes
| NCT ID | NCT04677205 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-03-30 |
| Primary Completion | 2023-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-03-30 with a primary completion date of 2023-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Mediastinal lymph node (LN) involvement (N2) in non-small cell lung cancer (NSCLC) concerns 15% of resectable tumors and is associated with a poor prognosis and an overall survival reaching 9 to 49%. Literature fails to provide any definitive consensus regarding the management of these patients, except for the platinum-based doublet chemotherapy. The N2 involvement remains a matter of debate because of its not yet well-classified heterogeneity. Regarding anatomy, the Mountain and Dresler's regional LN classification for lung cancer staging remains the reference. Different studies classified IIIA-N2 disease into 4 groups, in addition to the skip-N2 phenomenon: minimal-N2, N2 single station, N2 multiple stations, and bulky-N2. Other subgroups were recently proposed for the 8th edition of the TNM: N2a1 - single station skip, N2a2 - single station non-skip, N2b - multiple stations. The French National Cancer Institute (INCa) proposed guidelines, but in case of cN2 staging without mediastinal infiltration, guidelines remained imprecise ("resectability should be discussed for each case") and suggested surgery first, or induction chemotherapy, or concomitant chemoradiation. Thus, optimal management of cIIIA-N2 remains controversial but complete tumor resection can be related to long-term survival in some patients, including 10 years after surgery \[1\]. In this situation, the identification of markers that will help select IIIA-N2 patients who will benefit from surgical resection is mandatory.
Eligibility Criteria
Inclusion Criteria: * Adult patient, men and women age \>18 years * Patients operated with a curative intent for an IIIA-cN2 NSCLC * Social security affiliation * Written informed consent for patient included in part 2 (prospective) or not opposing the use of this data for patient included in part 1 (retrospective) Exclusion Criteria: * Patient with T4, R1 or R2 surgical resection, sublobar resection, no radical lymphadenectomy * Patient under protectives measures * Pregnancy or breast-feeding
Contact & Investigator
Helene BLONS, PharmD PhD
PRINCIPAL INVESTIGATOR
Hôpital Européen Georges-Pompidou
Frequently Asked Questions
Who can join the NCT04677205 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04677205 currently recruiting?
Yes, NCT04677205 is actively recruiting participants. Contact the research team at antlegras@gmail.com for enrollment information.
Where is the NCT04677205 trial being conducted?
This trial is being conducted at Bordeaux, France, Clamart, France, Marseille, France, Nice, France and 8 additional locations.
Who is sponsoring the NCT04677205 clinical trial?
NCT04677205 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Helene BLONS, PharmD PhD at Hôpital Européen Georges-Pompidou. The trial plans to enroll 200 participants.
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