| Protocol ID | NCT00006332 |
| Registration Date | 2000-10-05 |
| Status | completed |
| Sponsor | National Center for Research Resources (NCRR) |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | – |
| Last Patient Out | – |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT00006332
Treatment of Hepatocellular Carcinoma With Tetrathiomolybdate
| Field |
GLM
glm-5.1 7689ms / 8552 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4715ms / 9762 tok |
OPENAI
gpt-4o Thinking: o3 3696ms / 8408 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
other
shaky reasoning✓ Unanimous
Initial: other
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — Patients are recruited from General Liver clinic and Liver Transplant clinic, indicating outpatient clinic-based treatment delivery rather than inpatient hospital care.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention is delivered to outpatients in a general liver and liver transplant clinic setting, not requiring hospital admission.
|
OK |
| feasibility |
feasibility RCT
N/A → feasibility RCT
shaky reasoning✓ Unanimous
Initial: N/A
Requery: feasibility RCT — The trial is explicitly described as a pilot study with a small sample size of 10 patients, and despite having a clinical primary outcome (preventing tumor progression), the language and enrollment count indicate it is not designed as a fully powered effectiveness trial.
|
feasibility RCT
feasibility RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — The study explicitly states it is a 'pilot study of 10 patients' with primary outcome to prevent tumor progression, indicating this is a feasibility/pilot trial rather than a fully powered effectiveness study.
|
feasibility RCT
feasibility RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — The study is described as a 'pilot study' with only 10 patients, which indicates it aims to assess feasibility.
|
OK |
| intervention_pharmacologic | yes | yes | yes | 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 | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub |
not yet FDA/EMA approved
not yet FDA/EMA approved → not yet FDA/EMA approved
shaky reasoning✓ Unanimous
Initial: not yet FDA/EMA approved
Requery: not yet FDA/EMA approved — Tetrathiomolybdate is an investigational drug being studied in a Phase 2 trial as an antiangiogenic agent for hepatocellular carcinoma and is not currently approved by the FDA or EMA for this indication.
|
not yet FDA/EMA approved
other → other → not yet FDA/EMA approved
shaky reasoning✓ Unanimous
Initial: other
Requery: other — Tetrathiomolybdate is a copper-chelating agent used as an anti-angiogenic therapy, which doesn't fit into the specific categories of controlled substances, off-label use, not yet FDA approved drugs, chemotherapy, immunotherapy, radiation, or phytotherapies.
Thinking: not yet FDA/EMA approved — Tetrathiomolybdate is an experimental antiangiogenic agent being tested in a Phase 2 trial for HCC, following a prior Phase I trial.
|
not yet FDA/EMA approved
other → not yet FDA/EMA approved → not yet FDA/EMA approved
shaky reasoning✓ Unanimous
Initial: other
Requery: not yet FDA/EMA approved — Tetrathiomolybdate is an experimental drug not yet approved by the FDA/EMA for this indication.
Thinking: not yet FDA/EMA approved — Tetrathiomolybdate is an investigational copper-chelating drug with no current FDA or EMA approval.
|
OK |