Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment (REAL-NADIM)

August 3, 2023 updated by: Fundación GECP

This is an observational, prospective, multicentre and nationwide study.

The study enroll resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.

The primary objective of this study is evaluating whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is an observational, multicenter, one-arm, non-comparative, prospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of blood samples at five times and patient data, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.

Approximately 100 resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world will be recruited for this study in Spain. With this figure, it can be estimated whether ctDNA, both baseline and its negativization, has a role as a prognostic marker in the evolution of these patients in real-life conditions.

The primary objective of this study is evaluate whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.

The study is planned with the recruitment of patients over a year to a follow-up of 36 months post-surgery.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eva Pereira
  • Phone Number: +34934302006
  • Email: gecp@gecp.org

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Not yet recruiting
        • Hospital Universitario de A Coruna
        • Contact:
          • Joaquín Mosquera, MD
        • Principal Investigator:
          • Joaquín Mosquera, MD
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario de Alicante
        • Contact:
          • Bartomeu Massuti, MD
        • Principal Investigator:
          • Bartomeu Massuti, MD
      • Barcelona, Spain, 08028
        • Recruiting
        • Hospital Universitari Quiron Dexeus
        • Contact:
          • Maria González, MD
        • Principal Investigator:
          • Maria González, MD
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d' Hebron
        • Contact:
          • Alex Martínez, MD
        • Principal Investigator:
          • Alex Martínez, MD
      • Bilbao, Spain, 48013
        • Not yet recruiting
        • Hospital de Basurto
        • Contact:
          • Mª Ángeles Sala, MD
        • Principal Investigator:
          • Mª Ángeles Sala, MD
      • Córdoba, Spain, 14004
        • Not yet recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Isidoro Carlos Barneto, MD
        • Principal Investigator:
          • Isidoro Carlos Barneto, MD
      • Girona, Spain, 17007
        • Not yet recruiting
        • ICO Girona, Hospital Josep Trueta
        • Contact:
          • Joaquim Bosch, MD
        • Principal Investigator:
          • Joaquim Bosch, MD
      • Jaén, Spain, 23007
        • Recruiting
        • Hospital Universitario de Jaén
        • Contact:
          • Ana Laura Ortega Granados, MD
        • Principal Investigator:
          • Ana Laura Ortega Granados, Md
      • Lugo, Spain, 27003
        • Not yet recruiting
        • Hospital Universitario Lucus Augusti
        • Contact:
          • Natalia Fernández, MD
        • Principal Investigator:
          • Natalia Fernández, MD
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Javier de Castro, MD
        • Principal Investigator:
          • Javier de castro, MD
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
          • Jaime Rubio, MD
        • Principal Investigator:
          • Jaime Rubio, MD
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Carlos Aguado, MD
        • Principal Investigator:
          • Carlos Aguado, MD
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Universitario Regional de Málaga
        • Principal Investigator:
          • Manuel Cobo, MD
        • Contact:
          • Manuel Cobo, MD
      • Palma De Mallorca, Spain, 07198
        • Not yet recruiting
        • Hospital Universitari Son Llatzer
        • Contact:
          • Francisco Javier Garcia, MD
        • Principal Investigator:
          • Francisco Javier Garcia, MD
      • Valencia, Spain, 46026
        • Not yet recruiting
        • Hospital Universitario La Fe
        • Contact:
          • Oscar Juan-Vidal, MD
        • Principal Investigator:
          • Oscar Juan-Vidal, MD
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clinico de Valencia
        • Contact:
          • Paloma Martín, MD
        • Principal Investigator:
          • Paloma Martín, MD
      • Valladolid, Spain, 47003
        • Not yet recruiting
        • Hospital Clínico Universitario de Valladolid
        • Contact:
          • Rafael López, MD
        • Principal Investigator:
          • Rafael López, MD
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Germans Trias i Pujol
        • Contact:
          • Maria Saigí, MD
        • Principal Investigator:
          • Maria Saigí, MD
    • Iruña
      • Pamplona, Iruña, Spain, 31008
        • Not yet recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • Lucia Teijeira Teijeira, MD
        • Principal Investigator:
          • Lucia Teijeira, MD
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
          • Mariano Provencio, MD
        • Principal Investigator:
          • Mariano Provencio, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.

Description

Inclusion Criteria:

  • 1. Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients' stage IIIB with T3N2 disease according to 8th edition can be included.
  • 2. Tumor should be considered resectable before study entry by a multidisciplinary team
  • 3. ECOG 0-1
  • 4. Age ≥ 18 years at time of study entry
  • 5. Patients that are going to be treated with neoadjuvant treatment before surgery
  • 6. Patient capable of proper therapeutic compliance and accessible for correct follow-up
  • 7. Patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.

Exclusion Criteria:

  • 1. Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
  • 2. No possibility of venipuncture
  • 3. Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Study group
The study is based on a blood sample analysis in stage IIIA non-small lung cancer patients that are going to receive neoadjuvant treatment in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. Prospective information about treatment after neoadjuvant treatment and after the last blood extraction will not be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and progression free survival (PFS).
Time Frame: From date of end of neoadjuvant treatment and before surgery until the date of progression free survival, assessed up to 24 months
To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and PFS
From date of end of neoadjuvant treatment and before surgery until the date of progression free survival, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and overall survival.
Time Frame: From date of end of neoadjuvant treatment and before surgery until the date of death, assessed up to 24 months
To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and Overall Survival
From date of end of neoadjuvant treatment and before surgery until the date of death, assessed up to 24 months
To evaluate whether there is a significant association between ctDNA clearance and pathological complete response or major pathologic response.
Time Frame: From the end of neoadjuvant treatment and before surgery until the death of complete response or MPR, assessed up to 24 months
To assess the association between the baseline ctDNA and ctDNA clearance with each one of the two outcomes: after complete response or major pathologic response (MPR).
From the end of neoadjuvant treatment and before surgery until the death of complete response or MPR, assessed up to 24 months
To identify somatic mutations in ctDNA that predispose to a better/worse overall survival
Time Frame: From the date of extraction of blood in pretreatment period until the date of major pathologic response or death, assessed up to 24 months
To identify somatic mutations in ctDNA in the pre-treatment plasma that predispose to a better/worse overall survival.
From the date of extraction of blood in pretreatment period until the date of major pathologic response or death, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación GECP

Investigators

  • Study Chair: Mariano Provencio, MD, President of Grupo Español de Cáncer de Pulmón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GECP 21/05_REAL-NADIM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoadjuvant Treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe