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Cancer Patients Diagnosed With Unsuspected Venous Thromboembolism (VTE) on Routine Computed Tomography (CT) Scans

29. august 2019 opdateret af: M.D. Anderson Cancer Center

A Prospective Study of Cancer Patients Diagnosed With Unsuspected Venous Thromboembolism (VTE) on Routine Computed Tomography (CT) Scans

This is a prospective study with the following objectives:

Primary Objective:

  1. To estimate the prevalence of unsuspected VTE in oncology patients on routine staging CT scans of the thorax, abdomen and pelvis.

    Secondary Objectives:

  2. To identify symptoms commonly associated with VTE that are present in cancer patients undergoing routine staging CT scans with findings of unsuspected VTE.
  3. To identify the risk factors and demographic characteristics in outpatient cancer patients associated with the development of unsuspected VTE.
  4. To determine the incidence of recurrence of new VTE in patients with unsuspected VTE at 3 and 6 months of follow-up.

Studieoversigt

Status

Ukendt

Intervention / Behandling

Detaljeret beskrivelse

Patients diagnosed with cancer are routinely scheduled for staging CT scans. The CT scans are obtained to stage a new cancer diagnosis, to restage a cancer after treatment initiation or to evaluate abnormal masses, disease progression or metastasis. The study population will include outpatients scheduled for routine CT scan of the chest, abdomen and/or pelvis.

While patients are waiting in the Diagnostic Imaging waiting area, they will be invited to participate in the study. Study eligibility will be determined by administering a screening questionnaire. Cancer patients who meet the eligibility criteria will be asked to participate in the study. It is imperative that the patient completes the surveys and not the caregiver. A caregiver may lend assistance in transcribing the information but may not complete the instruments independent of the patient.

Many of these tools are brief and the estimated completion time should be approximately 15 to 30 minutes. Additionally completing the instruments will not extend beyond the time the patient is in the CT scan waiting area prior to the scheduled study.

On the day of study enrollment, patients will be asked to complete Brief Fatigue Inventory (BFI), MD Anderson Symptom Inventory (MDASI), Dyspnea Numerical Scale (DNS), Cancer Dyspnea Scale (CDS), ECOG/Zubrod Performance scale, Depression Anxiety Stress Scale (DASS 21), VTE Symptom Enrollment Questionnaire and Functional Assessment of Cancer Therapy-General (FACT-G). The patients will also complete a questionnaire on symptoms of VTE such as chest pain, pain or swelling of the extremities and other common symptoms reported in VTE patients.

VTE Symptom Follow-up Questionnaire:This instrument was designed for this study. Patients will be asked at 3 and 6 months the treatments received, recurrence of VTE, incidence of bleeding episodes and other health related conditions.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

1187

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas MD Anderson Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will include cancer outpatients, 18 years or older, scheduled for routine CT scan of the chest, abdomen and/or pelvis at UT MD Anderson Cancer Center.

Beskrivelse

Inclusion Criteria:

  1. Patients with a diagnosis of cancer.
  2. Subjects must be 18 years or more.
  3. Male and female patients are eligible for enrollment.
  4. Patients who are scheduled for routine outpatient cancer staging using CT scans.
  5. Patients must be able to complete the required survey tools independently.
  6. Patients must be able to speak, read and write English.

Exclusion Criteria:

  1. Patients who have a clinically suspected VTE and/or scheduled for CT scans for suspected VTE.
  2. Patients not willing to complete survey tools.
  3. Prior history of PE or DVT.
  4. Eastern Cooperative Oncology Group (ECOG)/Zubrod Performance Status score of 4.
  5. Patients currently on anticoagulation therapy (low molecular weight heparin, fondaparinux, dalteparin, warfarin or unfractionated heparin). Patients on heparin flushes for indwelling catheters will not be excluded.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Unsuspected VTE
Prevalence of unsuspected VTE in oncology patients on routine staging CT scans of the thorax, abdomen and pelvis
Survey tools and VTE Symptom Follow-up Questionnaire

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Prevalence of Unsuspected Venous Thromboembolism (VTE) Rate
Tidsramme: Day of enrollment, 3 months (+/- 7 days) and 6 months (+/- 7 days) from study enrollment and during 3 and 6 months follow-up
Day of enrollment, 3 months (+/- 7 days) and 6 months (+/- 7 days) from study enrollment and during 3 and 6 months follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Carmen Escalante, MD, M.D. Anderson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2009

Primær færdiggørelse (Forventet)

1. juni 2020

Studieafslutning (Forventet)

1. juni 2021

Datoer for studieregistrering

Først indsendt

18. juni 2009

Først indsendt, der opfyldte QC-kriterier

19. juni 2009

Først opslået (Skøn)

22. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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