Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy

September 27, 2022 updated by: UNC Lineberger Comprehensive Cancer Center
The purpose of this study is to investigate the level of Circulating Tumor Cells (CTCs) in cancer patients before and after undergoing treatment regimens where the primary treatment modality is radiation therapy (XRT). Specifically, there is interest in the change in CTCs pre- and post- XRT, both in absolute and relative terms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

CTCs measurements will be taken pre- and post-RT treatment. CTCs measurements will also be taken during treatment. The CTCs measurements from this study will provide essential information for the power and sample size considerations for future translational studies, particularly for those looking to identify biomarkers possibly associated with CTCs and tumor response activity after XRT, and to adequately power more formal statistical comparisons of important associations between CTCs and patient characteristics and outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill, Department of Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing radiation treatments at Lineberger Comprehensive Cancer Center at UNC Hospitals for one of eight cancer types: head and neck, cervical, rectal, lung, prostate, endometrial, metastatic breast, and oligometastatic cancer with any solid tumor histology. Additionally, patients undergoing immunotherapy at Lineberger Comprehensive Cancer Center at UNC Hosptials, or undergoing induction chemotherapy for treatment of head and neck cancers.

Description

Inclusion Criteria:

  • Histologically confirmed cancer, fitting one of the following cohorts: locally advanced head and neck cancer but no distant metastasis scheduled to receive radiotherapy to the head and neck region with or without chemotherapy/targeted therapy (palliative or curative intent); locally advanced cervical cancer without distant metastasis scheduled for radiotherapy to the pelvic region with or without chemotherapy/targeted therapy (palliative or curative intent); Stage I to III non-small cell lung cancer, without distant metastasis, scheduled to receive stereotactic body radiotherapy for early stage lung disease and/or external beam radiotherapy for locally advanced lung disease, with or without concurrent/sequential chemotherapy and/or targeted therapy (curative intent); metastatic prostate cancer scheduled for palliative radiotherapy, or biochemically recurrent prostate cancer following radical prostatectomy; scheduled for salvage prostatic fossa radiotherapy, with or without androgen deprivation or with high risk prostate cancer; locally advanced rectal cancer (no distant metastasis) scheduled to receive neoadjuvant chemoradiotherapy (curative intent); oligometastatic cancer, defined as any solid malignancy with< 5 measurable sites of metastatic disease, limited to a maximum of 3 anatomic organ systems, excluding the primary tumor and regional lymph nodes. At least 1 site of metastatic disease, but as many as all 5 sites, in addition to the primary tumor and regional lymph nodes, is amenable to local ablative therapy with external beam radiation, stereotactic cranial radiosurgery (SRS) or stereotactic body radiotherapy (SBRT). Treatment will be guided by multi-disciplinary evaluation and may also include surgery, chemotherapy or target agents at the discretion of the primary oncologists. Patients may present with oligometastatic disease or have oligometastatic disease recurrence after definitive therapy for localized disease; Melanoma or metastatic NSCLC scheduled to receive ipilimumab, nivolumab, and/or pembrolizumab.; Locally advanced head and neck cancer (HNSCC) scheduled to receive induction chemotherapy followed by radiotherapy; Metastatic breast cancer scheduled to receive any treatment, including radiation therapy and/or systemic/hormonal therapy; Stage III endometrial cancer scheduled to receive radiation therapy
  • Scheduled to initiate radiation for management of their disease, and schedule accommodates blood sample collection prior to radiation
  • Male and female of ≥18 years of age
  • Male and female patients capable of reproduction must agree to use medically acceptable methods of contraception, such as an intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during radiation therapy. Inclusion of females of childbearing potential requires a negative pregnancy test within 14 days prior to study initiation (part of standard of care in radiation oncology).
  • Written informed consent obtained and signed
  • Able to have blood collection without excessive difficulty

Exclusion Criteria:

  • Patient unwilling or unable to complete informed consent
  • Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician
  • Currently pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Head and Neck Cancer
Patient with locally advanced head and neck cancer but no distant metastasis scheduled to receive radiotherapy to the head and neck region with or without chemotherapy/targeted therapy (palliative or curative intent).
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Cervical Cancer
Patients with locally advanced cervical cancer without distant metastasis scheduled for radiotherapy to the pelvic region with or without chemotherapy/targeted therapy (palliative or curative intent).
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Non-Small Cell Lung Cancer
Patients with stage I to III non-small cell lung cancer, without distant metastasis, scheduled to receive stereotactic body radiotherapy for early stage lung disease and/or external beam radiotherapy for locally advanced lung disease, with or without concurrent/sequential chemotherapy and/or targeted therapy (curative intent).
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Rectal Cancer
Patients with locally advanced rectal cancer (no distant metastasis) scheduled to receive neoadjuvant chemoradiotherapy (curative intent).
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Metastatic Prostate Cancer
Patients with metastatic prostate cancer scheduled for palliative radiotherapy, or biochemically recurrent prostate cancer following radical prostatectomy scheduled for salvage prostatic fossa radiotherapy, with or without androgen deprivation, or with high risk prostate cancer.
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Oligometastatic Disease
Patients with oligometastatic cancer, defined as any solid malignancy with< 5 measurable sites of metastatic disease, limited to a maximum of 3 anatomic organ systems, excluding the primary tumor and regional lymph nodes. At least 1 site of metastatic disease, but as many as all 5 sites, in addition to the primary tumor and regional lymph nodes, is amenable to local ablative therapy with external beam radiation, stereotactic cranial radiosurgery or stereotactic body radiotherapy. Treatment will be guided by multi-disciplinary evaluation and may also include surgery, chemotherapy or target agents at the discretion of the primary oncologists. Patients may present with oligometastatic disease or have oligometastatic disease recurrence after definitive therapy for localized disease.
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Immunotherapy
Melanoma or metastatic NSCLC scheduled to receive ipilimumab, nivolumab, and/or pembrolizumab.
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Head and Neck Induction chemotherapy
Locally advanced head and neck cancer (HNSCC) scheduled to receive induction chemotherapy followed by radiotherapy.
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Metastatic Breast Cancer
Patients scheduled to receive any treatment, including radiation therapy, and/or systemic/hormonal therapy
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
Endometrial Cancer
Patients with stage III endometrial cancer, being treated with adjuvant radiation
Other: Blood draw
Blood samples will be collected at up to 4 time points before and during radiation. Blood will be collected at least 4 to 12 weeks post-treatment. Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To measure CTCs levels to evaluate the change pre- and post-treatment separately in 10 cohorts of patients receiving radiation therapy.
Time Frame: 24 months post-radiation
24 months post-radiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in CTC levels from Baseline to Post-RT treatment and the correlation with local tumor response or pathological evaluation, depending on cohort
Time Frame: 24 months post-radiation
24 months post-radiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNC Lineberger Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dana Casey, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCCC1408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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