A Japanese prospective observational study to assess a correlation between pre-surgical analysis of ctDNA and post-surgical pathological upstaging in patients with resectable clinical stage IA-IB Non-Small Cell Lung Cancer (NSCLC)

JRCT ID: jRCT1050230194

Registered date:06/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Resectable clinical stage IA-IB Non-Small Cell Lung Cancer(NSCLC)
• Date of first enrollment: 25/12/2023
• Target sample size: 120
• Study type: Observational

Outcome(s)

Primary Outcome

To assess whether ctDNA positive status associates with increased likelihood of
clinical (cTNM) to pathological upstaging (pTNM) in patients with clinical stage I NSCLC (TNM ver. 8).

Secondary Outcome

- To assess whether ctDNA positive status associates with increased likelihood of clinical (cTNM) to pathological upstaging (pTNM) in patients with clinical stage I NSCLC (TNM ver. 8 and ver. 9) in adenocarcinoma and non-adenocarcinoma subgroups.

- To assess whether ctDNA positive status associates with increased likelihood of clinical (cTNM) to pathological upstaging (pTNM) in patients with clinical stage I NSCLC (TNM ver. 9).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients aged at least 18 years at the time of signing the ICF.

2. Willing and able to participate in all required study evaluations and procedures and provision of signed written informed consent to participate in the study.

3. Clinically diagnosed as resectable stage I (IA-IB) NSCLC using TNM ver. 8 (imaging data up to 56 days before surgery can be used).

4. CTR > 0.5. The CTR is the longest diameter of the solid part of the tumor divided by the total diameter, including the ground-glass opacity on CT.

5. Agree to provide whole blood samples collected pre-surgery to enable molecular profiling and ctDNA analysis (refer to Laboratory Manual for details).

6. Agree to provide pre-surgical tumor sample (if available) and surgical tumor tissue to enable molecular profiling and to attain pathological diagnosis at institution laboratory for assessed pathological stage, histology (adenocarcinoma or non-adenocarcinoma), EGFR and ALK status, PD-L1 levels and the presence of pathological risk factors (invasive tumor size > 2 cm, visceral pleural invasion, lympho-vascular invasion) and IASLC grade for invasive adenocarcinoma (2020 system; Moreira et al 2020).

Exclude criteria

1. Histological examination of pre-surgical biopsy (if performed) confirms non-adenocarcinoma histology.
(Note: if pre-surgical biopsy is not performed prior to surgery, patients with clinically suspected NSCLC are eligible for inclusion in the study if NSCLC histology is confirmed on post-surgical pathology)

2. Molecular testing of pre-surgical biopsy (if performed) confirms targetable alteration in EGFR or ALK (EGFR or ALK mutant status) on local testing.
(Note: EGFR or ALK mutant patients confirmed on post-surgical molecular testing are eligible for inclusion).

3. Patients with synchronous lung primary tumors are not eligible for inclusion.

4. History of any other invasive solid or hematological malignancy diagnosed within the preceding 3 years and/or undergone definitive treatment for invasive solid or hematological malignancy in the past 3 years. Exceptions include adequately resected nonmelanoma skin cancer (basal cell carcinoma of the skin or squamous cell carcinoma of the skin) and curatively treated in situ disease.

5. Patient taking cytotoxic or demethylating agents such as methotrexate.

6. Previous or current participation in another GRAIL study. 'Participation' is defined as having signed consent and provided a blood sample.

Related Information

• Primary Sponsor: Hibi Kazushige