Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01869218
Eligibility Criteria:
Inclusion Criteria:
* Have an advanced solid or hematological malignancy that is resistant to standard therapy or for which no standard therapy is available.
* Being considered for early phase clinical trials in which an investigational agent is used either alone or in combination with chemotherapy or radiation. Patients who decline to enroll in this companion study will not be denied participation in the primary treatment protocols. Patients who are participating in phase I-III clinical treatment trials in which a tissue biopsy is already required, or patients who have standard of care tumor biopsies or procedures planned, e.g. to confirm metastatic recurrence or palliative resection of tumor, would also be eligible for participation in this trial.
* Have a primary or metastatic tumor lesion that is amenable to biopsy or resection. Patients whose tumors cannot be safely biopsied by fine needle aspiration or core needle biopsy are still eligible to participate in the aspects of the trial involving collection of archival tumor and blood.
* Age ≥ 18 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Life expectancy \> 2 months.
* Creatinine clearance ≥ 50 mL/min (applicable only if undergoing CT-guided biopsy that requires IV contrast enhancement).
* For patients with advanced solid malignancies, adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥1,000/mm\^3, platelet count ≥ 50,000/mm\^3, white blood cell count (WBC) ≥ 3,000/ mm\^3, and hemoglobin ≥ 8 g/dL.
* International normalized ratio (INR) ≤ 1.5. Patients on warfarin therapy must be able to safely withhold warfarin or be bridged with low-molecular weight therapy and demonstrate an INR ≤ 1.5 prior to the biopsy.
* Able to understand and willingness to sign a written informed consent document, agreeing to baseline and/or post-treatment tumor biopsies and/or blood collection.
* Patients who do not qualify for tumor biopsy due to laboratory abnormalities are still eligible to participate in the aspects of the trial involving collection of blood.
Exclusion Criteria:
* Have a known or suspected bleeding disorder that in the investigator's opinion would increase the risk of bleeding from a biopsy procedure. Patients who do not qualify for tumor biopsy due to a known or suspected bleeding disorder are still eligible to participate in the aspects of the trial involving collection of archival tumor and blood.
* Patients will be excluded if their participation in this study for pre-treatment biopsy, in the investigator's opinion, will significantly delay enrollment and treatment on clinical trial. Patients who are waiting for slot availability or who are undergoing a required washout from prior therapy are eligible to enroll.
* Patients with active uncontrolled bacterial, fungal or viral infection.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.
* Pregnant or breast feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01869218
Study Brief:
Protocol Section:
NCT01869218