Format

Send to

Choose Destination
Acta Oncol. 2018 Feb;57(2):195-202. doi: 10.1080/0284186X.2017.1346381. Epub 2017 Jul 19.

Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative.

Author information

1
a Department of Surgery , Erasmus MC University Medical Center , Rotterdam , The Netherlands.
2
b Department of Surgery , Academic Medical Center, Cancer Center Amsterdam , Amsterdam , The Netherlands.
3
c Department of Medical Oncology , Academic Medical Center , Amsterdam , The Netherlands.
4
d Netherlands Comprehensive Cancer Organization , Utrecht , The Netherlands.
5
e Department of Medical Oncology , University Medical Center Utrecht , Utrecht , The Netherlands.
6
f Department of Radiation Oncology , Maastro Clinic , Maastricht , The Netherlands.
7
g Department of Medical Oncology , Meander Medisch Centrum , Amersfoort , The Netherlands.
8
h Department of Gastroenterology and Hepatology , Erasmus MC University Medical Center , Rotterdam , The Netherlands.
9
i Department of Radiology , Leiden University Medical Center , Leiden , The Netherlands.
10
j Department of Surgery , Maasstad Hospital , Rotterdam , The Netherlands.
11
k Department of Epidemiology and Biostatistics , VU University Medical Center , Amsterdam , The Netherlands.
12
l Department of Surgery , Reinier de Graaf Hospital , Delft , The Netherlands.
13
m Department of Medical Oncology , Zuyderland Medisch Centrum , Heerlen , The Netherlands.
14
n Department of Surgery , University Medical Center Utrecht , Utrecht , The Netherlands.
15
o Department of Medical Oncology , Isala, Zwolle , The Netherlands.
16
p Department of Pathology , VU University Medical Center, Cancer Center Amsterdam , Amsterdam , The Netherlands.
17
q Department of Surgery , Catharina Hospital , Eindhoven , The Netherlands.
18
r Department of Radiotherapy , Academic Medical Center, Cancer Center Amsterdam , Amsterdam , The Netherlands.
19
s Living with Hope , Heemstede , The Netherlands.
20
t Department of Medical Oncology , St. Antonius Hospital , Nieuwegein , The Netherlands.
21
u Department of Pathology , Netherlands Cancer Institute , Amsterdam , The Netherlands.
22
v Department of Surgery , Deventer Hospital , Deventer , The Netherlands.
23
w Research Department , Tilburg University , Tilburg , The Netherlands.
24
x Department of Medical Oncology , Rode Kruis Hospital , Beverwijk , The Netherlands.
25
y Department of Medical Oncology , Treant Zorggroep , Hoogeveen , The Netherlands.
26
z Department of Radiotherapy , Instituut Verbeeten , Tilburg , The Netherlands.
27
aa Department of Surgery , Netherlands Cancer Institute - Antoni van Leeuwenhoek , Amsterdam , The Netherlands.
28
ab Department of Surgery , Diakonessenhuis , Utrecht , The Netherlands.
29
ac Stichting voor Patiënten met Kanker aan het Spijsverteringskanaal (SPKS) , Utrecht , The Netherlands.
30
ad Department of Gastroenterology , Radboud University Medical Center , Nijmegen , The Netherlands.
31
ae Department of Medical Oncology , Leiden University Medical Center , Leiden , The Netherlands.
32
af Department of Medical Oncology , Flevoziekenhuis , Almere , The Netherlands.
33
ag Department of Medical Psychology , Academic Medical Center , Amsterdam , The Netherlands.
34
ah Department of Surgery , Kennemer Gasthuis , Haarlem , The Netherlands.
35
ai Department of Medical Oncology , Hospital Rivierenland , Tiel , The Netherlands.
36
aj Department of Medical Oncology , Tergooi Hospital , Hilversum , The Netherlands.
37
ak Department of Medical Oncology , Zuwe Hofpoort Hospital , Woerden , The Netherlands.
38
al Department of Epidemiology , University Medical Center Utrecht , Utrecht , The Netherlands.
39
am Department of Surgery , Ikazia Hospital , Rotterdam , The Netherlands.
40
an Department of Medical Oncology , Maastricht University Medical Center , Maastricht , The Netherlands.
41
ao Department of Surgery , Elisabeth-Tweesteden Hospital , Tilburg , The Netherlands.

Abstract

BACKGROUND:

The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients.

MATERIAL AND METHODS:

All patients aged ≥18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future.

RESULTS:

In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was >85%. The number of hospitals participating in the cohorts is steadily increasing.

CONCLUSION:

A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses the limitations of classical study designs. With this initiative, novel and innovative studies can be performed in an efficient, safe, and comprehensive setting.

PMID:
28723307
DOI:
10.1080/0284186X.2017.1346381
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Taylor & Francis
Loading ...
Support Center