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Open Access Highly Accessed Study protocol

Diagnosis delay and follow-up strategies in colorectal cancer. Prognosis implications: a study protocol

Salvador Pita Fernández1*, Sonia Pértega Díaz1, Beatriz López Calviño1, Paloma González Santamaría1, Teresa Seoane Pillado1, Francisco Arnal Monreal2, Francesc Maciá3, María Antonia Sánchez Calavera4, Alejandro Espí Macías5, Manuel Valladares Ayerbes6, Alejandro Pazos7, Margarita Reboredo López6, Luis González Saez8, María Ramos Montserrat9, Josep María Segura Noguera10, Isabel Monreal Aliaga11, Luis González Luján12, María Martín Rabadán13, Cristiane Murta Nascimento3, Olga Pueyo14, Marta Maia Boscá Watts5, Elena Cabeza Irigoyen15, Montserrat Casmitjana Abella16, Marina Pinilla17, Ana Costa Alcaraz18, Amador Ruiz Torrejón19, Andrea Burón Pust3, Concepción García Aranda17, María de Lluc Bennasar20, Sergio Lafita Mainz21, Maite Novella22, Hermini Manzano23, Catalina Vadell24, Esther Falcó25 and Magdalena Esteva26

Author Affiliations

1 Clinical Epidemiology and Biostatistics Unit, A Coruña Hospital, Hotel de Pacientes 7ª Planta, As Xubias 84, A Coruña, 15006, Spain

2 Department of Anatomical Pathology, A Coruña Hospital, As Xubias 84, A Coruña, 15006, Spain

3 Evaluation and Clinical Epidemiology Department, Hospital del Mar, Passeig Maritim 25-29, Barcelona, 08003, Spain

4 Canal Imperial Primary Care Center, Paseo Colón 4, Zaragoza, 50006, Spain

5 Department of Gastroenterology, University Clinic Hospital of Valencia, Avenida Blasco Ibáñez 17, Valencia, 46010, Spain

6 Department of Oncology, A Coruña Hospital, As Xubias 84, A Coruña, 15006, Spain

7 Department of Information and Communication Technologies, Computer Science Faculty, University of A Coruña, Campus de Elviña s/n, A Coruña, 15071, Spain

8 Department of Surgery, A Coruña Hospital, As Xubias 84, A Coruña, 15006, Spain

9 Deparment of Public Health, Balearic Department of Health, Font i Monteros s/n, Palma de Mallorca, 07003, Spain

10 Lluis Saye Primary Care Centre, Torres I Amat 8, Barcelona, 08001, Spain

11 Monreal del Campo Primary Care Centre, Pirineos 2, Monreal Del Campo, Teruel, 44300, Spain

12 Serrería II Primary Care Centre, Valencia Institute of Health, Pedro de Valencia 26, Valencia, 46022, Spain

13 Can Misses Primary Care Centre, Avinguda De La Pau s/n, Eivissa, 07800, Spain

14 Aliaga Primary Care Centre, Polígono Industrial El Quiñón s/n, Teruel, 44150, Spain

15 Health Plan Agency, Balearic Department of Health, Cecilio Metelo 18, Palma de Mallorca, 07003, Spain

16 Clinical Epidemiology Unit, Hospital del Mar, Passeig Maritim 25-29, Barcelona, 08003, Spain

17 Delicias Norte Primary Care Centre, Santa Orosia 46, Zaragoza, 50010, Spain

18 Nazaret Primary Care Centre, Parque Nazaret 7, Valencia, 46024, Spain

19 Functional Informatization Unit, Balearic Department of Health, Reina Esclaramunda 9, Palma de Mallorca, 07003, Spain

20 Balearic Health System, Primary Care Management, Calle Mestre Perosi 17, Palma de Mallorca, 07008, Spain

21 Pyrinees High Resolution Hospital, Calzada de Rapit s/n, Jaca, 22700, Spain

22 Department of Gastroenterology, Hospital Can Misses, Carre Corona 32, Eivissa, 07800, Spain

23 Department of Oncology, Hospital Son Dureta, Carre Andrea Dòria 55, Palma de Mallorca, 07014, Spain

24 Department of Oncology, Hospital Manacor, Carretera Manacor-port d'Alcúdia s/n, Manacor, Mallorca, 07500, Spain

25 Department of Oncology, Hospital Son Llatzer, Carretera Manacor km 4, Palma Mallorca, 07198, Spain

26 Primary Health Care Research Unit, Primary Health Care Mallorca District, Balearic Health Service, Reina Esclaramunda 9, Palma de Mallorca, 07003, Spain

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BMC Cancer 2010, 10:528  doi:10.1186/1471-2407-10-528

Published: 5 October 2010

Abstract

Background

Controversy exists with regard to the impact that the different components of diagnosis delay may have on the degree of invasion and prognosis in patients with colorectal cancer. The follow-up strategies after treatment also vary considerably. The aims of this study are: a) to determine if the symptoms-to-diagnosis interval and the treatment delay modify the survival of patients with colorectal cancer, and b) to determine if different follow-up strategies are associated with a higher survival rate.

Methods/Design

Multi-centre study with prospective follow-up in five regions in Spain (Galicia, Balearic Islands, Catalonia, Aragón and Valencia) during the period 2010-2012. Incident cases are included with anatomopathological confirmation of colorectal cancer (International Classification of Diseases 9th revision codes 153-154) that formed a part of a previous study (n = 953).

At the time of diagnosis, each patient was given a structured interview. Their clinical records will be reviewed during the follow-up period in order to obtain information on the explorations and tests carried out after treatment, and the progress of these patients.

Symptoms-to-diagnosis interval is defined as the time calculated from the diagnosis of cancer and the first symptoms attributed to cancer. Treatment delay is defined as the time elapsed between diagnosis and treatment. In non-metastatic patients treated with curative intention, information will be obtained during the follow-up period on consultations performed in the digestive, surgery and oncology departments, as well as the endoscopies, tumour markers and imaging procedures carried out.

Local recurrence, development of metastases in the follow-up, appearance of a new tumour and mortality will be included as outcome variables.

Actuarial survival analysis with Kaplan-Meier curves, Cox regression and competitive risk survival analysis will be performed.

Discussion

This study will make it possible to verify if the different components of delay have an impact on survival rate in colon cancer and rectal cancer. In consequence, this multi-centre study will be able to detect the variability present in the follow-up of patients with colorectal cancer, and if this variability modifies the prognosis. Ideally, this study could determine which follow-up strategies are associated with a better prognosis in colorectal cancer.