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This study is a prospective longitudinal investigation. Data on disease-related information, gut microbiota composition, cancer-related symptoms, dietary intake, and levels of pro-inflammatory cytokines, LPS were collected repeatedly at the following time points: before chemotherapy initiation, at the end of induction chemotherapy or Re-induction I, at 8 weeks after induction or re-induction therapy, at three months after induction or re-induction therapy, as well as weekly between chemotherapy initiation and the end of induction chemotherapy or Re-induction I. The aim is to explore the relationship between gut microbiota composition and cancer-related symptoms.
This study is a prospective longitudinal investigation. (1) Describe the composition characteristics and dynamic changes of the gut microbiota in children with ALL, assessed weekly from before chemotherapy initiation until the end of induction chemotherapy or Re-induction I, as well as at 8 weeks and three months after the completion of induction or re-induction therapy.
(2) Describe the severity levels and dynamic changes of cancer-related symptoms in children with ALL, assessed weekly from before chemotherapy initiation until the end of induction chemotherapy or Re-induction I, as well as at 8 weeks and three months after the completion of induction or re-induction therapy.
(3) Investigate the correlations between gut microbiota composition, lipopolysaccharide (LPS), inflammatory cytokines (IL-6, IL-1β, TNF-α), and serotonin (5-HT) with cancer-related symptoms in children with ALL, assessed at the time points specified in (1) and (2).
(4) Explore the main factors influencing the characteristics of gut microbiota composition in children with ALL from baseline to three months after the completion of induction or re-induction therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaires assessed children with acute lymphoblastic leukemia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires set | Other | Planned to undergo a complete cycle of induction chemotherapy, with repeated collection of data including disease-related information, cancer-related symptoms, dietary records, and pro-inflammatory cytokine questionnaires. These data will be collected at the following time points: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherapy until the end of induction chemotherapy or Re-induction I. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-related symptoms | The cancer-related symptoms will be assessed by Children's Therapy-Related Symptom Checklist (TRSC) | before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherap |
| Cancer-related symptoms | The cancer-related symptoms of sleep will be assessed by Pittsburgh Sleep Quality Index (PSQI) | before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherap |
| Cancer-related symptoms | The cancer-related symptoms of anxiety and depression will be assessed by Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) | before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherap |
| Gut microbiota signature | Gut microbiota signature will be assessed by fecal sample from children | before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherap |
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Inclusion Criteria:
Exclusion Criteria:
- (1) Presence of gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.) or recent gastrointestinal surgery.
(2) Previous treatment with probiotics or fecal microbiota transplantation.
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138 children with acute lymphoblastic leukemia planned to undergo a full cycle of induction chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Wei Xia, Phd | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University; The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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fecal sample
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| fecal sample collecting | Other | Planned to undergo a complete cycle of induction chemotherapy, with repeated collection of fecal sample. These data will be collected at the following time points: before the initiation of chemotherapy, upon completion of induction chemotherapy or Re-induction I, at 8 weeks post-induction or re-induction therapy, at three months post-induction or re-induction therapy, as well as weekly from the start of chemotherapy until the end of induction chemotherapy or Re-induction I. |
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| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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