Protocol: A011202
Medical Condition: Breast
Title: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation In Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy.
Primary Objective: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy.
Intervention: Patients will be randomized to one of two study groups if cancer-positive lymph nodes are identified during surgery or at final pathology. Patients will either have axillary lymph node dissection and radiation treatment combined, or only radiation treatment.
Eligibility:
- Patients must be at least 18 years of age.
- Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy).
- No inflammatory breast cancer.
- No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix.
- No neoadjuvant endocrine therapy.
- No neoadjuvant radiation therapy.
More eligibility criteria must be met.
Protocol: CONNECT
Medical Condition: MF/AML/MDS
Title: The Myelofibrosis (MF), Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
Primary Objectives: To evaluate the effectiveness and safety of therapeutic options used in the treatment of MF and to describe current and evolving patterns for diagnosis, prognosis, treatment, clinical monitoring and outcome measures in patients with MDS and AML.
Intervention: No intervention, this study is observational only.
Eligibility:
- Must be able to provide written informed consent form.
- Newly diagnosed primary or secondary MDS, AML or ICUS. To be considered “newly diagnosed” a patient’s confirmed diagnosis must be made no more than 60 days prior to date of consent.
- MF patients who initiated their first active systemic treatment for MF and/or MF-related cytopenias within 60 days prior to the date of consent. This cohort allows the enrollment of subjects with a diagnosis of MDS/MPN.
- Cohort assignment confirmed by Central Eligibility Review
- AML patient must be at least 55 years of age at the time of consent.
- MF, MDS, ICUS patient must be at least 18 years of age at the time of consent.
- Must be willing and able to complete enrollment and follow-up HRQoL instruments, for which patients must be proficient in either English or Spanish.
More eligibility criteria must be met.
Protocol: S1703
Medical Condition: Breast
Title: Randomized Non-inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients with Metastatic Hormone Receptor Positive HER-2 Negative Breast Cancer
Primary Objective: To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with STMDDM have non-inferior overall survival compared to patients monitored with usual care.
Intervention: Patients will be randomized to one of two study groups if eligibility criteria are met. Patients randomized to usual care will have imaging studies (modality and frequency per treating physician alone or in conjunction with STMs; frequency determined by treating physician). Patients randomized to the STMDDM intervention will have disease specific STM evaluation every 4-8 weeks without imaging until an elevation of at least one disease specific STM. In the event of an elevated STM, the patient will have imaging within 4 weeks to evaluate for disease progression.
Eligibility:
- Patients must be ≥ 18 years of age.
- Patients must have a diagnosis of hormone receptor positive (ER+ and/or PR+), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease.
- Patients must have been tested for the following breast cancer specific Serum Tumor Markers (STM) after diagnosis of metastatic disease and within ±14 days of initiation of first-line systemic treatment for metastatic disease:
- CEA (must be tested)
- CA 15-3 or CA27.29 (at least one of these must be tested).
- Patients must have systemic radiographic imaging prior to initiation of systemic therapy or within 30 days of initiation of treatment for metastatic breast cancer and prior to registration.
- Patients must be willing to obtain disease monitoring (imaging and/or serum tumor markers) from a consistent facility. Imaging and STMs do not need to be completed at the same facility.
- Patients must not be currently enrolled or plan to participate in a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule.
More eligibility criteria must be met.
Protocol: S1823
Medical Condition: Germ Cell Tumors
Title: A Prospective Observational Cohort Study to Assess miRNA 371 For Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors
Primary Objective: To estimate the positive predictive value within each of the early stage testicular seminoma and nonseminoma groups using plasma miRNA 371 expression at relapse to detect germ cell malignancy.
Intervention: No intervention, this study is observational only.
Eligibility:
- Patients must have a new diagnosis of germ cell tumor confirmed pathologically or serologically (diagnostic elevation of HCG/AFP). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible.
- If surgery is planned, male patients with Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to screening.
- Patients must be screened within 42 days after diagnosis and prior to initiation of a management plan or treatment for the disease.
- Patients must be ≥ 18 years of age.
- Patients must have initial imaging, laboratory and other clinical evaluations performed within 42 days prior to screening.
- Patients must agree to submit required specimens for defined translational medicine studies. These specimens are drawn at the same time as standard laboratory evaluations.
More eligibility criteria must be met.
Protocol: CEDAR Study
Medical Condition: Endometrial Hyperplasia
Title: Personalized Genetic Medicine to Prevent Invasive Uterine Cancer and Unnecessary Hysterectomies
Purpose: The purpose of the study is to learn if specific types of pre-cancerous endometrial hyperplasia respond better or worse to progestin treatment. Researchers are hoping to find out how the endometrium responds to treatment with progestin from the Levonorgestrel IUD.
Intervention: No intervention, this study is observational only.
Eligibility:
- Pathology confirmed endometrial biopsy results of complex hyperplasia +/- nuclear atypia (pre-cancerous endometrial hyperplasia).
- Patients must have a treatment plan that includes the Levonorgestrel Intrauterine Device (LNG IUD) for a duration of 3-4 months.
- Willingness to have repeat endometrial biopsies at 3-4 and 6-8 months post treatment initiation (unless they choose hysterectomy).
- No prior history of endometrial cancer.
- No tamoxifen use within the last 5 years.
Protocol: GET FIT Prostate
Medical Condition: Prostate
Title: Group Exercise Training for Fall prevention and functional Improvements during and after Treatment for Prostate cancer
Design: The study is a 3-group, single-blind, parallel design randomized controlled trial. Participants in each study group will attend supervised 1-hr classes, 3 days a week for 6 months (a remote version of the study is also available almost entirely online.) Participants will be asked to travel to the research site to complete physical function tests and health surveys 4 times over 12 months.
Intervention:
ARM 1: Functional Balance (similar to tai chi) – A continuous, flowing sequence of individually choreographed movements.
ARM 2: Functional Strength – Functional movement pattern exercises using weighted vests.
ARM 3: Functional Mobility – Whole body flexibility exercises performed in a seated or lying position.
Eligibility:
- Diagnosed with histologically confirmed prostate cancer.
- Received ≥ 6-month course of ADT within the last 10 years
- Completed any surgery, radiation or chemotherapy ≥ 6 weeks prior to enrollment and no concurrent adjuvant therapy other than ADT for prostate cancer
More eligibility criteria must be met.
For additional information, call 503-346-0444 ext. 2
E-mail: exercise@ohsu.edu
www.ohsu.edu/getfitprostate
Study Opening Soon (May 2021)
Protocol: AR
Medical Condition: Multiple Tumor Sites
Title: Augmented Reality-Based Education for Patient Undergoing Radiation Therapy Treatment
Primary Objective: To determine if augmented reality technology can improve understanding for cancer patients undergoing radiation therapy.
Intervention: Patients will view a personalized 3D rendition of their own radiotherapy treatment in AR rather than a generic treatment plan.
Eligibility:
- Patients are eligible to participate if they are planning to receive radiotherapy and have or will undergo CT simulation in preparation for receiving radiotherapy
- Patients must by >18 years of age
- Must not have a history of vertigo, motion sickness, or headaches associated with 3-D media headsets.
- Must not be legally blind.
- Must not have a history of epilepsy or seizure disorder.
- Must not be deaf.
Treatment/Screening for Treatment Studies – Not currently recruiting
Protocol: EA9161
Medical Condition: CLL
Title: A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
Primary Objective: To compare the progression free survival (PFS) of the time limited administration of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax to Ibrutinib-Obinutuzumab in untreated CLL patients younger than 70 years of age.
Treatment: Patients will be randomized to one of two study groups. Arm A involves treatment with Ibrutinib, obinutuzumab and venetoclax. Arm B involves treatment with Ibrutinib and obinutuzumab.
Eligibility:
- Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria.
- No prior chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal anti-body therapy for treatment of CLL or SLL
- Age ≥ 18 years and < 70.
- ECOG performance status between 0-2.
- Life expectancy of ≥ 12 months.
More eligibility criteria must be met.
Protocol: Lung-MAP – LUNGMAP Screening
Medical Condition: Lung
Title: A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer
Primary Objective: To test patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol.
Intervention: No intervention, this is a screening protocol to determine eligibility for other protocols.
Eligibility Screening Criteria:
- Patients must have pathologically proven non-small cell lung cancer (all histologic types) confirmed by tumor biopsy and/or fine-needle aspiration.
- Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment.
- Patients must not have a known EGFR mutation or ALK fusion
- Patients must be ≥ 18 years of age.
- Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥ 0.2 mm3 tumor volume
More eligibility criteria must be met.