Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Papilloma

Nasal Polyps

Polyps

Nose Diseases

Papilloma, Inverted

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Pathological Conditions, Anatomical

The study group consisted of patients following a surgical removal of sinonasal papiloma, in which the SCCA blood levels were assessed in pre-defined intervals.

An endoscopic endonasal surgical device is used to remove the sinonasal papilomas in the study subjects.

Surgical removal of sinonasal papiloma

Pavel Kominek, doc.MD,PhD,MBA

This prospective study aimed to evaluate the usefulness of squamous cell carcinoma antigen (SCCA) as a clinical marker of sinonasal inverted papilloma (IP). The potential benefit of SCCA in the diagnosis of unilateral nasal pathology and as a marker of hidden recurrence was evaluated as well.

Blood samples from patients with sinonasal IP were examined to determine serum SCCA levels before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and postoperative levels of SCCA were compared.

INTRODUCTION Squamous cell carcinoma antigen (SCCA) is a protein with a strong homology to the family of protease inhibitors known as serpins. SCCAs are cytoplasmic proteins: they are found in normal squamous epithelia, and in elevated levels in the serum of patients with squamous cell carcinomas, especially in cases of uterine cervix carcinoma, lung carcinoma, and head and neck squamous cell carcinoma. SCCA is clinically useful, especially for the staging of uterine cervix carcinoma (risk of lymph node metastasis). It is also a useful marker for monitoring during follow-up and therapy, and increasing SCCA levels may predict carcinoma relapse. Recent studies have shown a close relationship between SCCA and sinonasal inverted papilloma (IP).

IP is a relatively infrequent, benign sinonasal tumour. Careful long-term follow-up after radical surgery is necessary when treating IP, owing to its malignant potential and high recurrence rate. Distinguishing between inflammatory changes and recurrence of IP can sometimes be difficult. The purpose of this study was to determine the benefit of SCCA serum level evaluation in patients with IP.

MATERIAL AND METHODS Study design This prospective study was performed in accordance with the Declaration of Helsinki, the criteria of good clinical practice, and all applicable regulatory requirements. Written informed consent was obtained from all participants before the initiation of any procedure.

Patients with IP treated at the Department of Otolaryngology, Faculty of Medicine, University of Ostrava were included in the study. At least three years of follow-up after surgery was required for inclusion of a patient in the study.

Blood samples from enrolled patients were examined to determine serum SCCA levels before surgery, the day after surgery, and every 6 months during follow-up. Preoperative and postoperative SCCA levels were compared. The changes in SCCA levels during follow-up were evaluated.

Biochemical analysis Serum SCCA levels were assayed using an immunofluorescence assay with monoclonal antibodies (B.R.A.H.M.S SCC KRYPTOR kit, Hennigsdorf, Germany). The normal serum level of SCC antigen is 0-1.5 µg/l.

Statistical analysis Statistical analysis of the correlation between preoperative and postoperative serum SCCA levels was performed using Student's t-test for paired data. Differences with p \< 0.05 were considered statistically significant.

Squamous Cell Carcinoma Antigen Analysis at the University Hospital Ostrava

Squamous Cell Carcinoma Antigen as a Marker of Sinonasal Inverted Papilloma

The levels of SCCA were assessed before and after the surgical procedure.

The levels of SCCA were assessed at six months after the surgical procedure and every six months during the follow-up period.

University Hospital Ostrava

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Niraparib

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

PARP inhibitors therapy until disease progression

Ovarian cancer patients with PARP inhibitors according to the NCCN guideline and their instructions.

PARP inhibitors

Jing Ni, MD

Xiaoxiang Chen, MD,PhD

Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. However, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers PARPi. We intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for PARPi.

This study intends to conduct a systematic real-world study to observe the relationship between the clinical characteristics of EOC patients and the efficacy of PARPi based on our existing research foundation and stratified analyse these correlations by BRCA and HRD status.

The Clinical Markers for PARP Inhibitors-related Efficacy in Ovarian Cancer

A Real-world Study of Clinical Markers for PARP Inhibitors in Epithelial Ovarian Cancer

Contact Prof. Chen and Dr. Ni for primary data.

ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.

PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.

DOR is defined as the time from the first date of response until the date of first documented progression.

DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.

Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 to further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Squamous Cell Carcinoma Antigen Analysis at the University Hospital Ostrava	NCT01827423	Nasal Polyps Nasal Diseases Papilloma	Surgical remova...	18 Years -	University Hospital Ostrava
The Clinical Markers for PARP Inhibitors-related Efficacy in Ovarian Cancer	NCT04582552	Ovarian Cancer Clinical Marker PARP Inhibitor	PARP inhibitors	18 Years -	Jiangsu Cancer Institute & Hospital

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