| Protocol ID | NCT02877368 |
| Registration Date | 2016-08-24 |
| Status | completed |
| Sponsor | CHU de Reims |
| Country | France |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2014-05-01 |
| Last Patient Out | 2014-10-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT02877368
Sarcopenia in Patients With Gastrointestinal Stromal Tumours
| Field |
GLM
glm-5.1 9691ms / 8641 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4949ms / 9912 tok |
OPENAI
gpt-4o Thinking: o3 5906ms / 8482 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
hospital
shaky reasoning✓ Unanimous
Initial: hospital
|
other
other
shaky reasoning✓ Unanimous
Initial: other
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The trial does not specify a distinct location for intervention delivery, potentially involving outpatient or community settings as it involves routine CT scans for sarcopenia and imatinib, which do not require hospitalization.
|
OK |
| feasibility | N/A | N/A | N/A | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention involves computed tomography (CT) scans for diagnostic/screening purposes, which falls under the screening category.
|
no
yes → no → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is an observational study using computed tomography imaging for measurement purposes, which falls under the screening/diagnostic category rather than being a therapeutic intervention.
Thinking: no — The CT scan is a screening/assessment tool used to evaluate sarcopenia, fitting the screening category.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The use of computed tomography (CT) scans as a non-invasive imaging technique for evaluating sarcopenia does not fit into the specified categories and aligns with environmental modifications.
Thinking: no — The only intervention is computed tomography imaging, which falls under the screening/diagnostic category.
|
OK |
| outcome_symptom |
yes
yes
shaky reasoning✓ Unanimous
Initial: yes
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The secondary outcome measures imatinib-induced toxicities including specific symptoms like nausea, diarrhea, vomiting, asthenia, muscle cramps, and arthralgia graded by NCI Common Toxicity Criteria.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The secondary outcomes explicitly list symptoms such as nausea, pruritus, diarrhea, vomiting, asthenia, and muscle cramps, which are direct assessments of symptoms.
|
OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The outcomes (sarcopenia and imatinib-induced toxicities) fit into symptom/medical categories rather than the specified other categories like caregiver outcomes or survival.
|
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes (sarcopenia assessment and imatinib-induced toxicities) are clinical/physiological measurements that fall under symptom/adverse event categories rather than other palliative care outcomes.
Thinking: yes — Outcomes measure sarcopenia (muscle mass index) and drug toxicities, not symptom relief, quality of life, dignity, or cost.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial includes an assessment of sarcopenia, which does not fall under symptom/QoL/dignity/cost categories.
Thinking: yes — Primary outcome is change in sarcopenia (muscle mass), which is a physiological/body‐composition metric not covered by symptom, QoL, dignity, or cost categories.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |