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This study aims to find out whether certain molecules in the blood, called microRNAs, are linked to how often and how severely people develop nerve damage from chemotherapy. The investigators will look at patients receiving cancer drugs known to affect the nerves, such as paclitaxel (used for lung cancer) and oxaliplatin (used for colorectal cancer).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel group | Experimental | Patients suffering from lung cancer and treated with paclitaxel |
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| Oxaliplatin group | Experimental | Patients suffering from colorectal cancer and treated with oxaliplatin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of blood concentrations of microRNAs | Diagnostic Test | day 1, day 43, and day 155. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentrations of microRNAs and severity score of sensory chemotherapy-induced peripheral neuropathy | Concentrations of microRNAs will be assessed in plasma, and severity score of sensory chemotherapy-induced peripheral neuropathy will be assessed using the QLQ-CIPN20 questionnaire. | day 1, day 43, and day 155 |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of sensory chemotherapy-induced peripheral neuropathy | The grade of sensory chemotherapy-induced peripheral neuropathy will be assessed using the NCI-CTCAE v6. | day 1, day 43, and day 155 |
| Severity score of motor chemotherapy-induced peripheral neuropathy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| David BALAYSSAC | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
Due to French regulations, the data cannot be shared.
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| Chemotherapy-induced peripheral neuropathy (CIPN) - grade | Other | day 1, day 43, and day 155. |
|
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| Pain assessement | Other | day 1, day 43, and day 155. |
|
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| Assessment of blood concentrations of neurofilament light chain | Diagnostic Test | day 1, day 43, and day 155. |
|
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| Neuropathic pain assessment | Other | day 1, day 43, and day 155. |
|
|
| Chemotherapy-induced peripheral neuropathy (CIPN) - severity | Other | day 1, day 43, and day 155. |
|
|
The severity score of motor chemotherapy-induced peripheral neuropathy will be assessed using the QLQ-CIPN20 questionnaire |
| day 1, day 43, and day 155 |
| Pain occurrence and severity | Pain will be assessed using a numerical rating scale (0-10). | day 1, day 43, and day 155 |
| Occurrence of neuropathic pain | Neuropathic pain will be assessed in patients reporting pain with a numerical rating scale (NRS) score of 4 or higher out of 10, and a DN4 questionnaire (short form) score of 3 or higher out of 7. | day 1, day 43, and day 155 |
| Concentrations of neurofilament light chain | The concentration of neurofilament light chain will be assessed in plasma. | day 1, day 43, and day 155 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D003110 | Colonic Neoplasms |
| D009443 | Neuritis |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000075002 | Bestrophins |
| ID | Term |
|---|---|
| D018118 | Chloride Channels |
| D007473 | Ion Channels |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005136 | Eye Proteins |
| D008562 | Membrane Glycoproteins |
| D008565 | Membrane Proteins |
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