Clinical trial · Interventional
Evidence Development in Cancer Treatment - Real World: PREDiCTrw
NCT06242912CI-TRIAL-00095781recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with therapy that has preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness in subjects with cancer. The goal of this study is to collect real world evidence with respect to quality of life and outcomes to support decision making.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QOL - quality of life | Behavioral | — | UNRESOLVED |
| Radiographic or laboratory evaluation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapy
- description
- Regular disease assessment (eg radiographic imaging) and quality of life (QOL) questionnaires
- interventionNames
- Behavioral: QOL - quality of life
- Diagnostic Test: Radiographic or laboratory evaluation
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
- description
- Overall survival from initiation of therapy
Secondary outcomes (5)
- measure
- Response rate
- timeFrame
- From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with cancer for which there remains ongoing questions regarding clinical effectiveness and/or cost effectiveness regarding a therapeutic agent * Eastern Co-operative Group (ECOG) 0-2 * Life expectancy of at least 12 weeks * Adequate hematologic and end organ function for drug treatment per the clinician's assessment * Asymptomatic or treated brain metastases permitted * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than 1% per year during the treatment period and for at least 5 months after the last dose. * For men: agreement to remain abstinent (refrain from heterosexual intercourse with a female partner of childbearing potential or who is pregnant) or use contraceptive measures, and agreement to refrain from donating sperm, during the treatment period and for at least 5 months after the last dose. * Ability to give informed consent for the study procedures defined in this protocol. Exclusion Criteria: * Treatment with any approved or investigational agent or participation in another clinical trial with therapeutic intent within 14 days prior to enrollment. * Inability to complete quality of life questionnaires * Pregnancy or breastfeeding. * Any significant cardiovascular disease, comorbidity (i.e. recent major infection, HIV, tuberculosis) or major surgical procedure within 21 days that in the opinion of the investigator renders the proposed treatment unsafe. * Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.