Circulating DNA in Surgically Treated NSCLC

NCT04037150 | Unknown

• 1 other identifier: Y2019SK007
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• The investigators will prospectively recruit 100 NSCLC patients. The cfDNA samples will be gathered before the surgery and postoperatively 4-6 weeks after surgery and at 6 and 12 months follow-up visits.
• This study aims to investigate the role of ctDNA in NSCLC patients treated with curative intent surgery.
• Preoperative ctDNA will be compared to primary tumor DNA to investigate the concordance of mutations and gained mutations from possible primary tumor cancer stem cell.
• Preoperative ctDNA findings will be tested for associations with baseline characteristics as well as clinically important factors such as TNM stage, histopathological findings, and tumor volume.
• The investigators aim to identify molecular residual disease (MRD) using multiple ctDNA samples after the surgery and search the associations with clinical recurrence and survival, with possible correlation to palliative chemotherapy response
• Using multiple ctDNA samples, the investigators will gather information about tumor heterogeneity, diversity of disease genotypes, and dynamic changes in ctDNA.
• If additional data from palliative immunotherapy (PD-L1 inhibitors) is available, the effect of this will be evaluated in the study.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; cfDNA

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Lead time to tumor recurrence detection by blood circulating tumor DNA versus clinical recurrence

  2 years

Secondary Outcomes (4)

• The concordance of ctDNA and tumor DNA

  1year

• Prognostic impact of ctDNA

  4 years

• ctDNA locoregional versus distant recurrence

  4 years

• The correlation of ctDNA and clinical features

  2 year

Interventions

Circulating tumor DNA DIAGNOSTIC_TEST

Circulating tumor DNA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgically treated NSCLC patients

You may not qualify if:

• prior metastatic solid cancer, hematological malignancy, known hereditary cancer syndrome, and pregnancy

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Institute for Molecular Medicine: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00270, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Circulating tumor DNA and tumor tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ilkka Ilonen, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Sutinen, BSC

CONTACT

+358505840449; eva.sutinen@hus.fi

Juuso Paajanen, MD

CONTACT

juuso.paajanen@hus.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

FI (1)