Background
Methods/design
FREGAT network
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Through retrospective cohorts, often driven in partnership with other scientific societies (FRENCH, Fédération de Recherche en Chirurgie (French Surgical Research Federation), AFC Association Française de Chirurgie (French Surgical Association)), numerous articles were published in journals with high impact factors;
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National and European prospective and randomized studies;
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A contribution to European research projects.
The FREGAT clinico-biological database
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The recruitment of all newly diagnosed patients who were completely treatment-naive for resectable or unresectable esophageal or gastric carcinoma (whatever the histological type, tumor stage and treatment strategy), received treatment at participating centers;
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A collection of tumor samples (pre-therapeutic biopsies, post-therapeutic biopsies, resected specimens) in compliance with current quality charters. These samples are stored at the relevant investigator center and are ideally frozen, although failing this, storage in paraffin wax is acceptable;
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The collection of blood samples has now been established at 6 centers where a great deal of recruitment has occurred and where a Biological Resources Center is located (Lille, Montpellier, Bordeaux, Marseille, Lyon, Rennes). This selection, basically linked to the available budget, can be adapted in the future depending on accessible financial resources and the dynamism of the selected centers. As is customary, these designated Biological Resources Centers will be responsible for the quality control of the samples;
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An epidemiological and socio-economic database;
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Questionnaires related to Human and Social Sciences;
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Questionnaires on Quality of Life.
Study population
Criteria for inclusion
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Patients with carcinoma of the esophagus, esophagogastric junction or stomach, those who were newly diagnosed by biopsy, no matter the cancer subtype, tumor stage or envisaged treatment.
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Man or woman ≥ 18 years of age.
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Treatment-naive in relation to these particular cancers.
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Covered by the social welfare scheme.
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Patients who voluntarily signed an informed consent form for retrieval of blood samples, completion of questionnaires and collection of patient information.
Criteria for exclusion
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Man or woman aged < 18 years.
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Person deprived of liberty or under trusteeship (including guardianship).
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Adult person incapable of expressing his or her consent.
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Patient already included in the FREGAT CBD.
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Patient refusal.
Aims of the research
Primary aim
Secondary aims
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To evaluate the impact of the range of usual treatment strategies on 3-year relapse, 3-year survival and health related quality of life;
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To identify the treatment related factors associated with the 3-year relapse to identify the most effective and the least toxic treatment combinations;
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To describe the individual, social and behavioral characteristics;
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To identify the individual and collective determining factors that influence the times for access to care and the start of treatment;
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To identify new prognostic factors and those that predict 3-year relapse.
Statistical plan
Variables collected
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Epidemiological: month, year and place of birth, sex, address.
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Clinical: WHO status, weight, height, comorbidities, date of first symptom, date of first consultation with a general practitioner and with a specialist, type of specialist consulted, risk factors, nutritional support, location of the tumor, cTNM stage, presence of other cancers.
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Biological: presence of albuminemia.
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Therapeutic: treatment strategy initially indicated, treatment given, chemotherapy, surgery, radiotherapy, evaluation of response and tolerance to treatment.
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Human and social sciences: data from the PEC and CARE questionnaires together with a visual analogue scale, HADS, MOS-SSS, and quality of life (QLQ-C30 and QLQ-OG25 questionnaires).
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Pathological: histological type, tumor differentiation, Lauren and WHO classification, radical nature of the surgery, (y)pTNM staging, and histological response to neoadjuvant treatment. Qualification of tumor samples: type and number of samples, distribution of samples for freezing and/or paraffin-embedding, and the evaluation of the quantity of tumor cells in cryopreserved and fixed tissues.
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Blood samples: type (EDTA, heparinized plasma, buffy coat, serum) and number of samples.
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Quality control of samples: time interval between resection of the tumor and when it is given to the pathologist, method of preservation, macroscopic examination, whether the fragment was frozen/embedded in paraffin, and storage (number of samples, identification).
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Follow-up: death (date and cause), follow-up duration, recurrence or relapse.
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The information gathered in the database extends from the point when the clinical follow-up of the patients begins, with the usual visits and follow-up methods, at each investigator center. The information must be updated on an annual basis. In addition, the information must be updated when an event such as relapse or death occurs. Finally, this list of variables, which have been established a priori, can be amended to reflect the research projects initiated by the scientific committee once these projects have been validated.
How the research is conducted in practice
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T1: On inclusion
- Quality of Life (QLQC30, QLQOG25).- Human and Social Sciences (PEC, CARE, MOS-SSS, HADS).
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T2: End of neoadjuvant treatment
- Quality of Life (QLQC30, QLQOG25).- Human and Social Sciences (PEC, CARE, MOS-SSS, HADS).
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T3: Surgery or endoscopic treatment for curative purposes
- Quality of Life (QLQC30, QLQOG25).- Human and Social Sciences (PEC, CARE, MOS-SSS, HADS).
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T4: End of adjuvant treatment. T4 is only applicable for patients receiving adhuvant treatment
- Quality of Life (QLQC30, QLQOG25).- Human and Social Sciences (PEC, CARE, MOS-SSS, HADS).
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Follow-up for 3 years: Follow-up is performed according to the practices applied at each center. The latest data regarding the patient are collected every year at a minimum and are entered in the e-CRF.
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T5: On recurrence or relapse
- Quality of Life (QLQC30, QLQOG25).- Human and Social Sciences (PEC, CARE, MOS-SSS, HADS).
Collection of biological samples
Nature | Volume | Pre-analytical conditions | By-product | Volume of Aliquots | Storage temperature |
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Blood on EDTA | 15 mL | Centrifugation 1500 g 15 min 4 °C | EDTA Plasma Buffy Coat Genomic DNA | 500 μL 1 mL 1 mL | −80 °C |
Blood on Heparin | 10 mL | Heparinized plasma | 500 μL | −80 °C | |
Blood on Dry Tube | 15 mL | Serum | 500 μL | −80 °C |
Participating teams and locations where the research is to take place
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37 participating centers, (i.e., 50 teams)
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The network of tumor banks
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The Biological Resource Centers
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The Data Processing Centers from the North-West Cancéropôle (Cancer Research Cluster)
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Lille University - Human and Social Sciences platform
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Caen Epidemiology platform
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Lille University - Methodology and Biostatistics platform
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Besançon Quality of Life platform