- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02449837
Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy
27. september 2022 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
162
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 99 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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).
|
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).
|
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).
|
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).
|
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.
|
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.
|
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.
|
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.
|
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
|
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
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To measure CTCs levels to evaluate the change pre- and post-treatment separately in 10 cohorts of patients receiving radiation therapy.
Tidsramme: 24 months post-radiation
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24 months post-radiation
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in CTC levels from Baseline to Post-RT treatment and the correlation with local tumor response or pathological evaluation, depending on cohort
Tidsramme: 24 months post-radiation
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24 months post-radiation
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Dana Casey, MD, University of North Carolina, Chapel Hill
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2014
Primær fullføring (Faktiske)
20. februar 2022
Studiet fullført (Faktiske)
20. februar 2022
Datoer for studieregistrering
Først innsendt
7. april 2015
Først innsendt som oppfylte QC-kriteriene
15. mai 2015
Først lagt ut (Anslag)
20. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. september 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. september 2022
Sist bekreftet
1. september 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LCCC1408
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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