Validation of a prospective data collection and registration protocol of stomach cancer cases

The manuscript is a worthy contribution to the scientific literature in the following ways: • An innovative article about gastric cancer cases in Brazil. • The journal, because of that, will be able to publish subjects about other country ́s data. • Proves the efficiency of a protocol for data collection and registration of stomach cancer cases. *Correspondence to: Lucas Motta Ganem, Faculty of Medical Sciences of Santa Casa de São Paulo, Rua Cesário Mota Júnior, 61, São Paulo-01221-906, Brazil, Tel: +5511991294041; E-mail: lmganem@hotmail.com Received: March 02, 2020; Accepted: March 10, 2020; Published: March 13, 2020 Introduction Stomach adenocarcinoma is one of the most frequent in Brazil and is a major cause of death from neoplasms. The high incidence and low cure rates justify research in this area [1]. In addition, other histological types should be mentioned: MALT lymphomas (Mucosal Associated Lymphoid Tissue), gastrointestinal stromal tumors (GIST), sarcomas and other less common. The prospective data collection allows careful monitoring and opens the possibility for research in numerous areas related to this disease. The use of records and techniques identical to the Japanese to perform D2 gastrectomies in Brazil aims to reproduce the good results of the Japanese. Other aspects are: the involvement of pathologists, which improves the quality of histological analysis; rigorous standardization and accuracy in annotations, in addition to photographic documentation, stimulating research in this manner [2]. The use of paper notes associated with the use of electronic data collection platforms allows maintaining the accuracy and security of the collection and analysis, which opens numerous research fronts: epidemiology and prevention, reconstruction techniques, quality of life, evaluation of different staging systems, lymph node dissection, adjuvant and neoadjuvant treatments, endoscopic methods of diagnosis and treatment, molecular studies, palliative treatments, prognosis, minimally invasive surgery, study of tumors other than adenocarcinoma. Thus, we aim to evaluate the efficiency and validate the patient data collection protocol for the following aspects: sex, age, staging, extension of lymphadenectomy, tumor site, Borrmann's macroscopic type, survival time, operability, extension of resection, histological types and subtypes. Demonstrate the efficiency and adequacy of the use of paper and electronic collection. Methods For the prospective data collection, a protocol based on the one created by the National Cancer Center in Tokyo was used. The cases were analyzed from January 1997 (the year in which the paper protocol was instituted in our service) until August 2018. The data were stored in two ways: on paper and through Excel spreadsheets. In the first year of collection, we asked to the previously operated patients authorization to record their data in the same protocol, in order to recover as much data as possible. To define macroscopic types in advanced tumors, it was used Borrmann's classification: type I polypoid, type II ulcerated, type III ulcerative-infiltrative and type IV – diffusely infiltrative. Early tumors were called type 0 for the record and non-classifiable tumors were called type V. Among the early ones, we have Types I protruding, IIa elevated surface, IIb flat surface, IIc depressed surface and type III excavated [3]. For the location of the tumors, we used the classification of the Japanese Association of Gastric Cancer which determines three regions of the stomach: U upper third, M middle third and L – lower third; when there is invasion of the duodenum, it is added the letter D and for the esophagus the letter E. In neoplasms that affect more than one area of the stomach, the first letter is the location where the epicenter or the largest tumor area is found, and then the other letters, also considering the localization. Within the neoplasms of the upper third, we included gastric stump neoplasms and, in those close to cardia, we used the Siewert classification [4]. Ganem LM (2020) Validation of a prospective data collection and registration protocol of stomach cancer cases Volume 6: 2-4 Clin Res Trials, 2020 doi: 10.15761/CRT.1000294 For the staging of adenocarcinoma, we used the International Union Against Cancer (UICC) seventh edition’s staging [5]. Lymph node dissections were classified as D0, D1, D1 + and D2 as proposed by the JGCA [6], and in D1 they could be curative or palliative. We also tried to determine the extension of stomach resection: total, subtotal or proximal, and operability. The Mann-Whitney test was used to verify age differences between different sexes.