Clinical trial NCT06079723: A Detailed Look At What Patients Experience In Medullary Thyroid Cancer Clinical Study
Official title: Analyzing the Patterns of Patient Engagement and Trends in Participation Observed in Medullary Thyroid Cancer Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Medullary Thyroid Cancer
Keywords: Medullary Thyroid Cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medullary thyroid cancer patients who are actively considering enrolling in an observational clinical study for said condition, but have not yet completed enrollment and randomization phases.

Brief summary: Clinical studies, with a distinct emphasis on medullary thyroid cancer, play a pivotal role in evaluating the safety and effectiveness of novel treatments for this condition. These trials serve as essential tools to determine whether new medications surpass conventional therapies, providing substantial evidence to endorse their broader adoption.

The primary objective is to meticulously examine trial completion rates and voluntary withdrawals within this specific patient group. By actively participating in this observational study plays a critical role in pushing medical knowledge forward and advancing care for individuals suffering from the medullary thyroid cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of medullary thyroid cancer
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* No serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Exclusion Criteria:

* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Any serious and/or unstable pre-existing medical disorders
* Patients who are currently receiving any other investigational drug.

Primary outcomes:
measure: Number of medullary thyroid cancer patients who decide to enroll in a clinical trial
timeFrame: 3 months
measure: Rate of medullary thyroid cancer patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Lam ET, Ringel MD, Kloos RT, Prior TW, Knopp MV, Liang J, Sammet S, Hall NC, Wakely PE Jr, Vasko VV, Saji M, Snyder PJ, Wei L, Arbogast D, Collamore M, Wright JJ, Moley JF, Villalona-Calero MA, Shah MH. Phase II clinical trial of sorafenib in metastatic medullary thyroid cancer. J Clin Oncol. 2010 May 10;28(14):2323-30. doi: 10.1200/JCO.2009.25.0068. Epub 2010 Apr 5.
citation: Elisei R, Schlumberger MJ, Muller SP, Schoffski P, Brose MS, Shah MH, Licitra L, Jarzab B, Medvedev V, Kreissl MC, Niederle B, Cohen EE, Wirth LJ, Ali H, Hessel C, Yaron Y, Ball D, Nelkin B, Sherman SI. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013 Oct 10;31(29):3639-46. doi: 10.1200/JCO.2012.48.4659. Epub 2013 Sep 3.
citation: Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24.