- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02449837
Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy
27. září 2022 aktualizováno: 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.
Přehled studie
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Aktuální)
162
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
-
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 99 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
To measure CTCs levels to evaluate the change pre- and post-treatment separately in 10 cohorts of patients receiving radiation therapy.
Časové okno: 24 months post-radiation
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24 months post-radiation
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Change in CTC levels from Baseline to Post-RT treatment and the correlation with local tumor response or pathological evaluation, depending on cohort
Časové okno: 24 months post-radiation
|
24 months post-radiation
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Dana Casey, MD, University of North Carolina, Chapel Hill
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. května 2014
Primární dokončení (Aktuální)
20. února 2022
Dokončení studie (Aktuální)
20. února 2022
Termíny zápisu do studia
První předloženo
7. dubna 2015
První předloženo, které splnilo kritéria kontroly kvality
15. května 2015
První zveřejněno (Odhad)
20. května 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
28. září 2022
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. září 2022
Naposledy ověřeno
1. září 2022
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- LCCC1408
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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