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CompletedNCT02803333ORIENUpdated Feb 27, 2023

Oncology Research Information Exchange Network (ORIEN) Lung Cancer Study

An observational study in Lung Cancer and Non-small Cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study summary

The Moffitt Cancer Center and PatientsLikeMe.com (PLM), an online patient community, are working together to better understand the patient's entire lung cancer experience, both inside and outside the doctor's office. By combining the data that is captured by their care team in the clinic with the data participants enter at their home on PatientsLikeMe.com, the investigators hope to improve patient-physician treatment decisions, so that the patient's personal treatment goals and quality of life have the highest chances of being fulfilled.

Read the detailed description

The aim of the study is to assess the real-world patient experience by evaluating the patients' quality of life, treatment toxicities, and clinical measures over a 6-month period. The ultimate goal of this research is to improve patient-physician treatment decisions, so that the patient's personal treatment goals and quality of life have the highest chances of being fulfilled.

Aim 1. To track the toxicities/side-effects of FDA approved molecular targeted agents, immunotherapies, and combinations of treatments for NSCLC in a clinical setting for six months.

Aim 2. To assess the impact of these treatment regimens on patient toxicities, symptoms, function, and quality of life, after adjustment for clinical factors and patient characteristics during the 6 month follow-up period.

02

Conditions studied

  • Lung Cancer
  • Non-small Cell Lung Cancer

Keywords

  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Diseases
  • Thoracic Neoplasms
03

In context

Lung Neoplasms

7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's enrollment of 75 is below the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 539 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Advanced non-small cell lung cancer patients (stage 3b/4) receiving treatment at the Moffitt Cancer Center (MCC) or The Ohio State University Comprehensive Cancer Center (OSUCCC)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • >= 18 years of age
  • Diagnosed with metastatic (stage 3b/4) non-small cell lung cancer (NSCLC)
  • The total combined sample size must include at least 100 people who received one or more treatments of PD-1/PDL-1 inhibitor treatment (immunotherapy), and 50 patients who received an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI). Patients receiving any other treatments will be tracked for treatment outcomes, as well as to serve as comparison participants during data analyses of outcomes associated with PD-1/PDL-1 or EGFR-TKI).
  • Consented separately to the Total Cancer Care (TCC) protocol
  • Have access to the internet
  • Willing to enroll in the free online health tracking and patient community "PatientsLikeMe"

Exclusion criteria

Exclusion Criteria:

  • Patients enrolled in Phase I clinical trial protocols
  • Patients enrolled in Phase II, III or IV clinical trials involving blinded therapies (patients in open label trials will be eligible)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No

Groups and cohorts

  • Data Capture Participants

    This is a prospective observational cohort study of advanced non-small cell lung cancer patients (stage 3b/4) receiving treatment at the Moffitt Cancer Center (MCC) or The Ohio State Comprehensive Cancer Center (OSUCCC) to assess treatment impact at monthly intervals from baseline to 6 months post-enrollment.

    Other: No Intervention

Interventions

  • OtherNo Intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Number of Participants with Cancer Treatment Changes

    Clinical, molecular, and patient-reported data will be collected from participants. Participants will be asked if their treatment course has changed and, if so, what changes have occurred. These questions are primarily meant to identify the number of patients who were switched from one treatment regimen (e.g., chemotherapy) to either PD-1/PDL-1 inhibitor treatment (immunotherapy) or tyrosine kinase inhibitors (TKIs).

    Time frame: 6 months post enrollment

07

Study locations

1 site
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Aug 2018, 18 months.

Of 578 non-industry observational studies under Lung Neoplasms, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 172. This study's 18 months is below that.

Counting every sponsor, half of 685 studies reached it within 56 months; a quarter within 29 and three quarters within 130.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2016
First posted
Jun 16, 2016
StartActual
Feb 16, 2017
Primary completionActual
Aug 18, 2018
CompletionActual
Nov 19, 2021
Last update
Feb 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02803333
Responsible party
Sponsor
First posted
Jun 16, 2016
Start date
Feb 16, 2017
Primary completion
Aug 18, 2018
Completion
Nov 19, 2021
Last update
Feb 27, 2023

Study contacts

Matthew Schabath, Ph.D.
principal investigator · H. Lee Moffitt Cancer Center and Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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