Establishing a detection method for CCNY: a potentially significant clinical investigative marker in NSCLC patients.

Background: CCNY, a novel cyclin family member, plays an increasingly important role in the progression of tumor invasion and metastasis, including lung cancer. However, the clinical significance of CCNY in non-small-cell lung cancer (NSCLC) patients is unknown.

Patients and methods: We prepared CCNY monoclonal antibodies, validated specific peptides by a peptide array, and established a double-antibody sandwich ELISA detection method. Then, we measured CCNY levels in 100 NSCLC patients and 50 healthy controls. A blinded validation was subsequently performed in 399 NSCLC patients and 150 healthy controls.

Results: We successfully prepared two specific mouse anti-human CCNY monoclonal antibodies and established a reliable and stable detection method. In the training set, serum CCNY was markedly increased in the NSCLC patients ( P <0.05) with an integrated area under the curve of 0.751. With further analysis of the CCNY levels, there were no differences in age, sex, smoking status, tumor location, histologic subtype, or tumor size, but differences were observed in lymphatic ( P <0.001) and distant ( P <0.001) metastases in NSCLC patients. The CCNY[+] patients had a shorter survival time and progression-free survival than CCNY[-] patients at 3-year follow-up ( P <0.001). The results were confirmed by the validation set.

Conclusion: Our study suggests that CCNY may be useful as a latent tumor marker to facilitate diagnosis and may be an effective indicator of tumor aggressiveness, playing an important role in the prognosis of NSCLC patients.