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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01781-54 | Other Identifier | ID-RCB number, ANSM |
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lack of inclusion
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Cirrhosis and cancers of the upper digestive tract, colorectal and ENT share common risk factors. Liver cirrhosis can change the elimination of cancer drugs.
Precise data on management and outcome of patients with liver cirrhosis undergoing chemotherapy are lacking. Most patients have been excluded from clinical trials evaluating conventional therapies.
The study of tolerance, side effects, and outcome in patients with cirrhosis could help improve chemotherapy management for better tolerance and efficacy.
The main objective is to estimate the frequency of liver cirrhosis among patients evaluated in CPR for ENT, upper digestive or colorectal cancer.
Secondary objective includes the evaluation ofthe impact of cirrhosis on the management of chemotherapy by comparing cirrhotic patients' outcomes with a control group of matched non-cirrhotic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhotic patients | Current care study. Data collection on oncological efficacy (Clinical, biological, imaging) Data collection on hepatology (clinical, biological, imaging) |
| |
| Non-cirrhotic patients | Current care study. Data collection on oncological efficacy (Clinical, biological, imaging) Data collection on hepatology (clinical, biological, imaging) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Current care study | Other | Observational study in two parts:
Exposed subjects will be patients with cirrhosis, included consecutively. Non-exposed subjects will be non-cirrhotic patients. They will be selected non-consecutively according to the following criteria, for matching to exposed subjects: age (±5 years), type of cancer (digestive vs. ENT), treatment stage (curative vs. palliative). Two unexposed subjects will be selected for 1 exposed subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of patients with ENT, upper digestive-tract or colorectal cancer with a diagnosis of cirrhosis | before the chemotherapy initiation, within 45 days of multidisciplinary board |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients receiving at least a first effective course of chemotherapy on all patients with a theoretical indication for chemotherapy | within 45 days of multidisciplinary board. | |
| Survival time | Survival time defined as the difference between the date of initiation of chemotherapy, |
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Inclusion Criteria:
Exclusion Criteria:
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The patients selected are patients with ENT, upper digestive-tract cancer and colorectal cancer from 2 hospitals: the University Hospital of Lille and the Oscar Lambret Centre.
The study population consists of patients with a theoretical indication of conventional chemotherapy according to the usual guidelines for the management presented in multidisciplinary board.
Prospective follow-up will be carried out on the population of patients receiving effective administration of a first course of chemotherapy.
Patients in theoretical indications who are not receiving chemotherapy will be included in the first part of the study, but prospective follow-up will not be performed in this population.
Exposed subjects who have received a first course of chemotherapy will be followed prospectively.
Non-exposed subjects will be matched according to age (+/-5 years), ECOG/WHO classification, chemotherapy protocol and tumour location and followed prospectively.
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| Name | Affiliation | Role |
|---|---|---|
| Massih Ningarhari, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | France | ||||
| Hôpital Claude Huriez, CHU |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D009369 | Neoplasms |
| D008103 | Liver Cirrhosis |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| the date of death, the date of last news or the point date (12 months). |
| Progression-free survival time | Progression-free survival time defined as the difference between the date of initiation of chemotherapy, the date of progression or death, the date of last news or the point date (12 months). | the date of initiation of chemotherapy, tthe date of progression or death, the date of last news or the point date (12 months). |
| Frequency of chemotherapy side effects according to CTCAE version 5.0 classification in cirrhotic patients who have received chemotherapy | Up to 5 years after chemotherapy |
| Lille |
| France |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |